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Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

Primary Purpose

Prostatic Hyperplasia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

dutasteride 0.5mg once daily for 4 years

tamsulosin 0.4mg once daily for 4 years

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring Combination Therapy, dutasteride, BPH

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria: A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: males, aged ≥50 years clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) International Prostate Symptom Score (IPSS) ≥12 points at Screening prostate volume ≥30 cc by transrectal ultrasonography; (TRUS) total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids) willing and able to give written informed consent and comply with study procedures fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication able to swallow and retain oral medication willing and able to participate in the study for the full 4 years. Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: total serum PSA >10.0ng/mL at Screening history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study. Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice. previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH. history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction. history of AUR within 3 months prior to Screening Visit. post-void residual volume >250mL (suprapubic ultrasound) at Screening. any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections). history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy. use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication). concurrent use of anabolic steroids use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study. use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study. Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study. use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments. hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs. concurrent use of drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin. history of hepatic impairment or abnormal liver function tests at Screening defined as alanine aminotransferase (ALT), aspartate aminotranferase (AST), and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome). history of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal or serum creatinine ≥1.5 mg/dL at Screening. prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible. history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient. any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management. history of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury. history of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy. history of unsuccessful treatment with finasteride or dutasteride history or current evidence of drug or alcohol abuse within the previous 12 months. participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding the Screening Visit and/or during the course of this study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

dutasteride

Combo

tamsulosin

Arm Description

dutasteride 0.5mg once daily

Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily

tamsulosin 0.4mg once daily

Outcomes

Primary Outcome Measures

Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.

A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.

Number of Participants With AUR or BPH-related Surgery

A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.

Secondary Outcome Measures

Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4

The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.

The Number of Participants With Each of the Five Components of BPH Clinical Progression

The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.

Number of Events of Symptom Deterioration at the Indicated Time Periods

The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).

Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria

A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.

Number of Participants With an Event of Post-baseline BPH-related Hematospermia

A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.

Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48

The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.

Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48

Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.

Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48

Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.

Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48

Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.

Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit?" If the answer to the question was "yes," the number of visits was recorded.

Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?". If the answer to the question was "yes," the number of Yes responses was recorded.

Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of visits was recorded.

Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of Yes responses was recorded.

Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?". If the answer to the question was "yes," the number of visits was recorded.

Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?". If the answer to the question was "yes," the number of visits was recorded.

Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48

The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.

Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48

The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has control of your urinary problems changed?".

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on control of your urinary problems?" Satisfact., satisfaction.

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on the strength of your urinary stream?". Satisfact., satisfaction.

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain prior to urinating?". Satisfact., satisfaction.

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain during urination?". Satisfact., satisfaction.

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?". Satisfact., satisfaction.

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Overall, how satisfied are you with the study medication and it's effect on your urinary problems?". Satisfact., satisfaction.

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Would you ask your doctor for the medication you received in this study?".

Full Information

NCT ID

NCT00090103

First Posted

August 24, 2004

Last Updated

January 16, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00090103

Brief Title

Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

Official Title

A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Detailed Description

A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Hyperplasia

Keywords

Combination Therapy, dutasteride, BPH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

4844 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dutasteride

Arm Type

Active Comparator

Arm Description

dutasteride 0.5mg once daily

Arm Title

Combo

Arm Type

Experimental

Arm Description

Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily

Arm Title

tamsulosin

Arm Type

Active Comparator

Arm Description

tamsulosin 0.4mg once daily

Intervention Type

Drug

Intervention Name(s)

dutasteride 0.5mg once daily for 4 years

Intervention Description

combination or single agent

Intervention Type

Drug

Intervention Name(s)

tamsulosin 0.4mg once daily for 4 years

Other Intervention Name(s)

dutasteride, tamsulosin

Intervention Description

combination agent or single agent

Primary Outcome Measure Information:

Title

Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.

Description

Time Frame

Years 1, 2, 3, and 4

Title

Number of Participants With AUR or BPH-related Surgery

Description

A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.

Time Frame

Baseline (Day 1) through Year 4

Secondary Outcome Measure Information:

Title

Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4

Description

Time Frame

Years 1, 2, 3, and 4

Title

The Number of Participants With Each of the Five Components of BPH Clinical Progression

Description

The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.

Time Frame

Baseline (Day 1) to Year 4

Title

Number of Events of Symptom Deterioration at the Indicated Time Periods

Description

Time Frame

Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)

Title

Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria

Description

Time Frame

Baseline (Day 1) through Year 4

Title

Number of Participants With an Event of Post-baseline BPH-related Hematospermia

Description

Time Frame

Baseline (Day 1) through Year 4

Title

Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit

Description

Time Frame

Every 3 months from Month 3 to Month 48

Title

Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.

Description

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?". If the answer to the question was "yes," the number of Yes responses was recorded.

Time Frame

Every 3 months from Month 3 to Month 48

Title

Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit

Description

Time Frame

Every 3 months from Month 3 to Month 48

Title

Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"

Description

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of Yes responses was recorded.

Time Frame

Every 3 months from Month 3 to Month 48

Title

Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)

Description

Time Frame

Every 3 months from Month 3 to Month 48

Title

Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)

Description

At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?". If the answer to the question was "yes," the number of visits was recorded.

Time Frame

Every 3 months from Month 3 to Month 48

Title

Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48

Description

Time Frame

Baseline and Months 12, 24, 36, 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)

Description

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on control of your urinary problems?" Satisfact., satisfaction.

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)

Description

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on the strength of your urinary stream?". Satisfact., satisfaction.

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)

Description

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain prior to urinating?". Satisfact., satisfaction.

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)

Description

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain during urination?". Satisfact., satisfaction.

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)

Description

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)

Description

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?". Satisfact., satisfaction.

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)

Description

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Overall, how satisfied are you with the study medication and it's effect on your urinary problems?". Satisfact., satisfaction.

Time Frame

Baseline and Months 12, 24, 36, and 48

Title

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)

Description

This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Would you ask your doctor for the medication you received in this study?".

Time Frame

Baseline and Months 12, 24, 36, and 48

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35234

Country

United States

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35242

Country

United States

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

GSK Investigational Site

City

Columbiana

State/Province

Alabama

ZIP/Postal Code

35051

Country

United States

Facility Name

GSK Investigational Site

City

Hoover

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

GSK Investigational Site

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix, Arizona

State/Province

Arizona

ZIP/Postal Code

86106

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

GSK Investigational Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90212

Country

United States

Facility Name

GSK Investigational Site

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

GSK Investigational Site

City

Glendora

State/Province

California

ZIP/Postal Code

91741

Country

United States

Facility Name

GSK Investigational Site

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

GSK Investigational Site

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Facility Name

GSK Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

GSK Investigational Site

City

Laguna Woods

State/Province

California

ZIP/Postal Code

92637

Country

United States

Facility Name

GSK Investigational Site

City

Los Angelas

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

GSK Investigational Site

City

los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

GSK Investigational Site

City

Modesto

State/Province

California

ZIP/Postal Code

95350

Country

United States

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95821

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

GSK Investigational Site

City

Torrance

State/Province

California

ZIP/Postal Code

90506

Country

United States

Facility Name

GSK Investigational Site

City

Vista

State/Province

California

ZIP/Postal Code

92084

Country

United States

Facility Name

GSK Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

GSK Investigational Site

City

Bay Pines

State/Province

Florida

ZIP/Postal Code

33744

Country

United States

Facility Name

GSK Investigational Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

GSK Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32114

Country

United States

Facility Name

GSK Investigational Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

GSK Investigational Site

City

New Smyrna Beach

State/Province

Florida

ZIP/Postal Code

32168

Country

United States

Facility Name

GSK Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

GSK Investigational Site

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

GSK Investigational Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32503

Country

United States

Facility Name

GSK Investigational Site

City

Pinecrest

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

GSK Investigational Site

City

Spring Hill

State/Province

Florida

ZIP/Postal Code

34609

Country

United States

Facility Name

GSK Investigational Site

City

St. Augustine

State/Province

Florida

ZIP/Postal Code

32086

Country

United States

Facility Name

GSK Investigational Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33702

Country

United States

Facility Name

GSK Investigational Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

GSK Investigational Site

City

Stuart

State/Province

Florida

ZIP/Postal Code

34996

Country

United States

Facility Name

GSK Investigational Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

GSK Investigational Site

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

Facility Name

GSK Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

GSK Investigational Site

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

GSK Investigational Site

City

Calhoun

State/Province

Georgia

ZIP/Postal Code

30701

Country

United States

Facility Name

GSK Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

GSK Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30066

Country

United States

Facility Name

GSK Investigational Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

GSK Investigational Site

City

Belleville

State/Province

Illinois

ZIP/Postal Code

62220

Country

United States

Facility Name

GSK Investigational Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

GSK Investigational Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61614

Country

United States

Facility Name

GSK Investigational Site

City

Wheaton

State/Province

Illinois

ZIP/Postal Code

60187

Country

United States

Facility Name

GSK Investigational Site

City

Winfield

State/Province

Illinois

ZIP/Postal Code

60190

Country

United States

Facility Name

GSK Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

GSK Investigational Site

City

Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

Country

United States

Facility Name

GSK Investigational Site

City

Newburgh

State/Province

Indiana

ZIP/Postal Code

47630

Country

United States

Facility Name

GSK Investigational Site

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46601

Country

United States

Facility Name

GSK Investigational Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

GSK Investigational Site

City

Murray

State/Province

Kentucky

ZIP/Postal Code

42071

Country

United States

Facility Name

GSK Investigational Site

City

Bossier City

State/Province

Louisiana

ZIP/Postal Code

71111

Country

United States

Facility Name

GSK Investigational Site

City

Laurel

State/Province

Maryland

ZIP/Postal Code

20724

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55417

Country

United States

Facility Name

GSK Investigational Site

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

GSK Investigational Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68102

Country

United States

Facility Name

GSK Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

GSK Investigational Site

City

Hillsborough

State/Province

New Jersey

ZIP/Postal Code

08844

Country

United States

Facility Name

GSK Investigational Site

City

Perth Amboy

State/Province

New Jersey

ZIP/Postal Code

08861

Country

United States

Facility Name

GSK Investigational Site

City

Somerville

State/Province

New Jersey

ZIP/Postal Code

08876

Country

United States

Facility Name

GSK Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

Country

United States

Facility Name

GSK Investigational Site

City

Bayshore

State/Province

New York

ZIP/Postal Code

11706

Country

United States

Facility Name

GSK Investigational Site

City

Garden City

State/Province

New York

ZIP/Postal Code

11530

Country

United States

Facility Name

GSK Investigational Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

GSK Investigational Site

City

Lewiston

State/Province

New York

ZIP/Postal Code

14092

Country

United States

Facility Name

GSK Investigational Site

City

Asheboro

State/Province

North Carolina

ZIP/Postal Code

27203

Country

United States

Facility Name

GSK Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27511

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28262

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28304

Country

United States

Facility Name

GSK Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Facility Name

GSK Investigational Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

GSK Investigational Site

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

GSK Investigational Site

City

Bellbrook

State/Province

Ohio

ZIP/Postal Code

45305

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

GSK Investigational Site

City

Fleetwood

State/Province

Pennsylvania

ZIP/Postal Code

19522

Country

United States

Facility Name

GSK Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02904

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Athes

State/Province

Texas

ZIP/Postal Code

75751

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

GSK Investigational Site

City

New Brunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

GSK Investigational Site

City

Texarkana

State/Province

Texas

ZIP/Postal Code

75503

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

GSK Investigational Site

City

Alexandria

State/Province

Virginia

ZIP/Postal Code

22304

Country

United States

Facility Name

GSK Investigational Site

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98004

Country

United States

Facility Name

GSK Investigational Site

City

Mountlake Terrace

State/Province

Washington

ZIP/Postal Code

98043

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

GSK Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

GSK Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

1111

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

1120

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

1416

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1181ACI

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

1405

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

1118

Country

Argentina

Facility Name

GSK Investigational Site

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

GSK Investigational Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

GSK Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

GSK Investigational Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

GSK Investigational Site

City

La Louvière

ZIP/Postal Code

7100

Country

Belgium

Facility Name

GSK Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

GSK Investigational Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-008

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90470-340

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Rio de Janeiro

ZIP/Postal Code

20 551-030

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04262-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1431/1000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Varna

ZIP/Postal Code

9002

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 1N1

Country

Canada

Facility Name

GSK Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3C 0N2

Country

Canada

Facility Name

GSK Investigational Site

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

GSK Investigational Site

City

Saint John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 4S8

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

Facility Name

GSK Investigational Site

City

Kentville

State/Province

Nova Scotia

ZIP/Postal Code

B4N 4K9

Country

Canada

Facility Name

GSK Investigational Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

GSK Investigational Site

City

Brantford

State/Province

Ontario

ZIP/Postal Code

N3R 4N3

Country

Canada

Facility Name

GSK Investigational Site

City

Courtice

State/Province

Ontario

ZIP/Postal Code

L1E 3C3

Country

Canada

Facility Name

GSK Investigational Site

City

Guelph

State/Province

Ontario

ZIP/Postal Code

N1H 5J1

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

GSK Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

M6A 4G5

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

GSK Investigational Site

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 7K8

Country

Canada

Facility Name

GSK Investigational Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6H 3P1

Country

Canada

Facility Name

GSK Investigational Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1H 7K4

Country

Canada

Facility Name

GSK Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

Facility Name

GSK Investigational Site

City

Scarborough

State/Province

Ontario

ZIP/Postal Code

M1P 2T7

Country

Canada

Facility Name

GSK Investigational Site

City

Scarborough

State/Province

Ontario

ZIP/Postal Code

M1S 4V5

Country

Canada

Facility Name

GSK Investigational Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 4T3

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M2K 2W1

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4C 5T2

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6A 3B5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6S 4W4

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 1N8

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3S 1Z1

Country

Canada

Facility Name

GSK Investigational Site

City

Saint Charles-Borromee

State/Province

Quebec

ZIP/Postal Code

J6E 6J2

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

GSK Investigational Site

City

St-Jerome

State/Province

Quebec

ZIP/Postal Code

J7Z 5T3

Country

Canada

Facility Name

GSK Investigational Site

City

Trois Rivieres

State/Province

Quebec

ZIP/Postal Code

G9A 3V7

Country

Canada

Facility Name

GSK Investigational Site

City

Hradec Kralove

ZIP/Postal Code

536 00

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Ostrava - Poruba

ZIP/Postal Code

708 52

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Praha 3

ZIP/Postal Code

130 00

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Praha 5

ZIP/Postal Code

150 18

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Praha 8

ZIP/Postal Code

180 71

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Roudnice nad Labem

ZIP/Postal Code

413 01

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

GSK Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

GSK Investigational Site

City

Fredericia

ZIP/Postal Code

7000

Country

Denmark

Facility Name

GSK Investigational Site

City

Randers

ZIP/Postal Code

8900

Country

Denmark

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

1162

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

Country

Estonia

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00150

Country

Finland

Facility Name

GSK Investigational Site

City

Kouvola

ZIP/Postal Code

45200

Country

Finland

Facility Name

GSK Investigational Site

City

Kuopio

ZIP/Postal Code

70100

Country

Finland

Facility Name

GSK Investigational Site

City

Pietarsaari

ZIP/Postal Code

68600

Country

Finland

Facility Name

GSK Investigational Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

GSK Investigational Site

City

Bully Les Mines

State/Province

Nord-Pas-de-Calais

ZIP/Postal Code

62160

Country

France

Facility Name

GSK Investigational Site

City

Agny

ZIP/Postal Code

62217

Country

France

Facility Name

GSK Investigational Site

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

GSK Investigational Site

City

Annecy

ZIP/Postal Code

74000

Country

France

Facility Name

GSK Investigational Site

City

Arras

ZIP/Postal Code

62000

Country

France

Facility Name

GSK Investigational Site

City

Athis Mons Cedex

ZIP/Postal Code

91200

Country

France

Facility Name

GSK Investigational Site

City

Besançon

ZIP/Postal Code

25000

Country

France

Facility Name

GSK Investigational Site

City

Bouchemaine

ZIP/Postal Code

49080

Country

France

Facility Name

GSK Investigational Site

City

Broglie

ZIP/Postal Code

27270

Country

France

Facility Name

GSK Investigational Site

City

Castelneau Le Nez

ZIP/Postal Code

34170

Country

France

Facility Name

GSK Investigational Site

City

Chambery

ZIP/Postal Code

73000

Country

France

Facility Name

GSK Investigational Site

City

Chambéry

ZIP/Postal Code

73000

Country

France

Facility Name

GSK Investigational Site

City

Chilly Mazarin

ZIP/Postal Code

91380

Country

France

Facility Name

GSK Investigational Site

City

Cournonterral

ZIP/Postal Code

34460

Country

France

Facility Name

GSK Investigational Site

City

Créteil cedex

ZIP/Postal Code

94010

Country

France

Facility Name

GSK Investigational Site

City

Domarin

ZIP/Postal Code

38300

Country

France

Facility Name

GSK Investigational Site

City

Epinay sur Orge

ZIP/Postal Code

91360

Country

France

Facility Name

GSK Investigational Site

City

Evreux Cedex

ZIP/Postal Code

27025

Country

France

Facility Name

GSK Investigational Site

City

Evreux

ZIP/Postal Code

27000

Country

France

Facility Name

GSK Investigational Site

City

Gif-sur-Yvette

ZIP/Postal Code

91190

Country

France

Facility Name

GSK Investigational Site

City

Grenoble

ZIP/Postal Code

38100

Country

France

Facility Name

GSK Investigational Site

City

La Seyne sur Mer

ZIP/Postal Code

83500

Country

France

Facility Name

GSK Investigational Site

City

Lamarque

ZIP/Postal Code

33460

Country

France

Facility Name

GSK Investigational Site

City

Laval

ZIP/Postal Code

53000

Country

France

Facility Name

GSK Investigational Site

City

Le Brusc

ZIP/Postal Code

83140

Country

France

Facility Name

GSK Investigational Site

City

Le Kremlin-Bicêtre

ZIP/Postal Code

94275

Country

France

Facility Name

GSK Investigational Site

City

Les Mureaux

ZIP/Postal Code

78130

Country

France

Facility Name

GSK Investigational Site

City

Lesparre Médoc

ZIP/Postal Code

33340

Country

France

Facility Name

GSK Investigational Site

City

Linas

ZIP/Postal Code

91310

Country

France

Facility Name

GSK Investigational Site

City

Longpont sur Orge

ZIP/Postal Code

91310

Country

France

Facility Name

GSK Investigational Site

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Name

GSK Investigational Site

City

Melun

ZIP/Postal Code

77007

Country

France

Facility Name

GSK Investigational Site

City

Meudon

ZIP/Postal Code

92190

Country

France

Facility Name

GSK Investigational Site

City

Meylan

ZIP/Postal Code

38240

Country

France

Facility Name

GSK Investigational Site

City

Mont de Marsan

ZIP/Postal Code

40000

Country

France

Facility Name

GSK Investigational Site

City

Montauban

ZIP/Postal Code

82017

Country

France

Facility Name

GSK Investigational Site

City

Montpelier

ZIP/Postal Code

34000

Country

France

Facility Name

GSK Investigational Site

City

Montpellier

ZIP/Postal Code

34000

Country

France

Facility Name

GSK Investigational Site

City

Montpellier

ZIP/Postal Code

34100

Country

France

Facility Name

GSK Investigational Site

City

Orléans Cedex 2

ZIP/Postal Code

45067

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

GSK Investigational Site

City

Pontonx Sur Adour

ZIP/Postal Code

40465

Country

France

Facility Name

GSK Investigational Site

City

Roanne

ZIP/Postal Code

42300

Country

France

Facility Name

GSK Investigational Site

City

Saint Chamond

ZIP/Postal Code

42400

Country

France

Facility Name

GSK Investigational Site

City

Saint Denis

ZIP/Postal Code

93200

Country

France

Facility Name

GSK Investigational Site

City

Saint Galmier

ZIP/Postal Code

42330

Country

France

Facility Name

GSK Investigational Site

City

Saint Germain Lespinasse

ZIP/Postal Code

42640

Country

France

Facility Name

GSK Investigational Site

City

Saint Sebastien de Morsent

ZIP/Postal Code

27180

Country

France

Facility Name

GSK Investigational Site

City

Saint-Egrève

ZIP/Postal Code

38120

Country

France

Facility Name

GSK Investigational Site

City

Saint-Georges d'Orques

ZIP/Postal Code

34680

Country

France

Facility Name

GSK Investigational Site

City

Sainte Suzanne

ZIP/Postal Code

53270

Country

France

Facility Name

GSK Investigational Site

City

Sanary

ZIP/Postal Code

83110

Country

France

Facility Name

GSK Investigational Site

City

Sarlat la Canéda

ZIP/Postal Code

24200

Country

France

Facility Name

GSK Investigational Site

City

Seysses

ZIP/Postal Code

31600

Country

France

Facility Name

GSK Investigational Site

City

Six-Fours les Plages

ZIP/Postal Code

83140

Country

France

Facility Name

GSK Investigational Site

City

Suresnes Cedex

ZIP/Postal Code

92151

Country

France

Facility Name

GSK Investigational Site

City

Toulon

ZIP/Postal Code

83200

Country

France

Facility Name

GSK Investigational Site

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

GSK Investigational Site

City

Vaucresson

ZIP/Postal Code

92420

Country

France

Facility Name

GSK Investigational Site

City

Verneuil-sur-Seine

ZIP/Postal Code

78480

Country

France

Facility Name

GSK Investigational Site

City

Villejuif Cedex

ZIP/Postal Code

94804

Country

France

Facility Name

GSK Investigational Site

City

Villeneuve-Les-Maguelone

ZIP/Postal Code

34750

Country

France

Facility Name

GSK Investigational Site

City

Vourey

ZIP/Postal Code

38210

Country

France

Facility Name

GSK Investigational Site

City

Aalen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73430

Country

Germany

Facility Name

GSK Investigational Site

City

Freiburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

79106

Country

Germany

Facility Name

GSK Investigational Site

City

Konstanz

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

78464

Country

Germany

Facility Name

GSK Investigational Site

City

Mosbach

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

74821

Country

Germany

Facility Name

GSK Investigational Site

City

Rottweil

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

78628

Country

Germany

Facility Name

GSK Investigational Site

City

Stockach

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

78333

Country

Germany

Facility Name

GSK Investigational Site

City

Aichach

State/Province

Bayern

ZIP/Postal Code

86551

Country

Germany

Facility Name

GSK Investigational Site

City

Amberg

State/Province

Bayern

ZIP/Postal Code

92224

Country

Germany

Facility Name

GSK Investigational Site

City

Augsburg

State/Province

Bayern

ZIP/Postal Code

86150

Country

Germany

Facility Name

GSK Investigational Site

City

Graefeling

State/Province

Bayern

ZIP/Postal Code

82166

Country

Germany

Facility Name

GSK Investigational Site

City

Neu-Ulm

State/Province

Bayern

ZIP/Postal Code

89231

Country

Germany

Facility Name

GSK Investigational Site

City

Schongau

State/Province

Bayern

ZIP/Postal Code

86956

Country

Germany

Facility Name

GSK Investigational Site

City

Wertingen

State/Province

Bayern

ZIP/Postal Code

86637

Country

Germany

Facility Name

GSK Investigational Site

City

Hagenow

State/Province

Brandenburg

ZIP/Postal Code

19230

Country

Germany

Facility Name

GSK Investigational Site

City

Lauchhammer

State/Province

Brandenburg

ZIP/Postal Code

01979

Country

Germany

Facility Name

GSK Investigational Site

City

Oranienburg

State/Province

Brandenburg

ZIP/Postal Code

16515

Country

Germany

Facility Name

GSK Investigational Site

City

Senftenberg

State/Province

Brandenburg

ZIP/Postal Code

01968

Country

Germany

Facility Name

GSK Investigational Site

City

Alzenau

State/Province

Hessen

ZIP/Postal Code

63755

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60326

Country

Germany

Facility Name

GSK Investigational Site

City

Fulda

State/Province

Hessen

ZIP/Postal Code

36037

Country

Germany

Facility Name

GSK Investigational Site

City

Giessen

State/Province

Hessen

ZIP/Postal Code

35390

Country

Germany

Facility Name

GSK Investigational Site

City

Kassel

State/Province

Hessen

ZIP/Postal Code

34123

Country

Germany

Facility Name

GSK Investigational Site

City

Koenigstein

State/Province

Hessen

ZIP/Postal Code

61462

Country

Germany

Facility Name

GSK Investigational Site

City

Marburg

State/Province

Hessen

ZIP/Postal Code

35039

Country

Germany

Facility Name

GSK Investigational Site

City

Schwalbach

State/Province

Hessen

ZIP/Postal Code

65824

Country

Germany

Facility Name

GSK Investigational Site

City

Grimmen

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

18507

Country

Germany

Facility Name

GSK Investigational Site

City

Parchim

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19370

Country

Germany

Facility Name

GSK Investigational Site

City

Delmenhorst

State/Province

Niedersachsen

ZIP/Postal Code

27753

Country

Germany

Facility Name

GSK Investigational Site

City

Holzminden

State/Province

Niedersachsen

ZIP/Postal Code

37603

Country

Germany

Facility Name

GSK Investigational Site

City

Oldenburg

State/Province

Niedersachsen

ZIP/Postal Code

26121

Country

Germany

Facility Name

GSK Investigational Site

City

Osnabrueck

State/Province

Niedersachsen

ZIP/Postal Code

49074

Country

Germany

Facility Name

GSK Investigational Site

City

Duelmen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48249

Country

Germany

Facility Name

GSK Investigational Site

City

Stadtlohn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48703

Country

Germany

Facility Name

GSK Investigational Site

City

Koblenz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56068

Country

Germany

Facility Name

GSK Investigational Site

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06114

Country

Germany

Facility Name

GSK Investigational Site

City

Hettstedt

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06333

Country

Germany

Facility Name

GSK Investigational Site

City

Merseburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06217

Country

Germany

Facility Name

GSK Investigational Site

City

Hohenstein-Ernsttal

State/Province

Sachsen

ZIP/Postal Code

09337

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04105

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04109

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04277

Country

Germany

Facility Name

GSK Investigational Site

City

Husum

State/Province

Schleswig-Holstein

ZIP/Postal Code

25813

Country

Germany

Facility Name

GSK Investigational Site

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24103

Country

Germany

Facility Name

GSK Investigational Site

City

Apolda

State/Province

Thueringen

ZIP/Postal Code

99510

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10627

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10719

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12167

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12347

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12681

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13053

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13439

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

14197

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 21

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 22

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

15126

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

154 52

Country

Greece

Facility Name

GSK Investigational Site

City

Patra

ZIP/Postal Code

265 00

Country

Greece

Facility Name

GSK Investigational Site

City

Polygyros

ZIP/Postal Code

63 100

Country

Greece

Facility Name

GSK Investigational Site

City

Thassaloniki

ZIP/Postal Code

564 34

Country

Greece

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1036.

Country

Hungary

Facility Name

GSK Investigational Site

City

Sopron

ZIP/Postal Code

9400

Country

Hungary

Facility Name

GSK Investigational Site

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Facility Name

GSK Investigational Site

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

GSK Investigational Site

City

Reykjavik

ZIP/Postal Code

101

Country

Iceland

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

31048

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

Country

Israel

Facility Name

GSK Investigational Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

GSK Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

GSK Investigational Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

GSK Investigational Site

City

Zrifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

GSK Investigational Site

City

Catanzaro

State/Province

Calabria

ZIP/Postal Code

88100

Country

Italy

Facility Name

GSK Investigational Site

City

Avellino

State/Province

Campania

ZIP/Postal Code

83100

Country

Italy

Facility Name

GSK Investigational Site

City

Castellamare di Stabia (NA)

State/Province

Campania

ZIP/Postal Code

80053

Country

Italy

Facility Name

GSK Investigational Site

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

GSK Investigational Site

City

San Felice a Cancello Caserta

State/Province

Campania

ZIP/Postal Code

81027

Country

Italy

Facility Name

GSK Investigational Site

City

Torre del Greco (NA)

State/Province

Campania

ZIP/Postal Code

80059

Country

Italy

Facility Name

GSK Investigational Site

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41100

Country

Italy

Facility Name

GSK Investigational Site

City

Udine

State/Province

Friuli-Venezia-Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00189

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16128

Country

Italy

Facility Name

GSK Investigational Site

City

Lecco

State/Province

Lombardia

ZIP/Postal Code

23100

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Facility Name

GSK Investigational Site

City

Ivrea (TO)

State/Province

Piemonte

ZIP/Postal Code

10015

Country

Italy

Facility Name

GSK Investigational Site

City

Novara

State/Province

Piemonte

ZIP/Postal Code

28100

Country

Italy

Facility Name

GSK Investigational Site

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10126

Country

Italy

Facility Name

GSK Investigational Site

City

Cagliari

State/Province

Sardegna

ZIP/Postal Code

09134

Country

Italy

Facility Name

GSK Investigational Site

City

Acireale (CT)

State/Province

Sicilia

ZIP/Postal Code

95124

Country

Italy

Facility Name

GSK Investigational Site

City

Bagno a Ripoli (FI)

State/Province

Toscana

ZIP/Postal Code

50126

Country

Italy

Facility Name

GSK Investigational Site

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50139

Country

Italy

Facility Name

GSK Investigational Site

City

Siena

State/Province

Toscana

ZIP/Postal Code

53100

Country

Italy

Facility Name

GSK Investigational Site

City

Portogruaro (VE)

State/Province

Veneto

ZIP/Postal Code

30026

Country

Italy

Facility Name

GSK Investigational Site

City

Pusan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

150-015

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kaunas

ZIP/Postal Code

LT-47144

Country

Lithuania

Facility Name

GSK Investigational Site

City

Kaunas

ZIP/Postal Code

LT-49287

Country

Lithuania

Facility Name

GSK Investigational Site

City

Klaipeda

ZIP/Postal Code

LT-92231

Country

Lithuania

Facility Name

GSK Investigational Site

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

GSK Investigational Site

City

Vilnius

ZIP/Postal Code

LT-10207

Country

Lithuania

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

Facility Name

GSK Investigational Site

City

Zapopan, Jalisco

State/Province

Jalisco

ZIP/Postal Code

45100

Country

Mexico

Facility Name

GSK Investigational Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45170

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico DF

ZIP/Postal Code

06720

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico, D.F.

ZIP/Postal Code

14050

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

ZIP/Postal Code

06700

Country

Mexico

Facility Name

GSK Investigational Site

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amstelveen

ZIP/Postal Code

1186 AM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1034 CS

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Arnhem

ZIP/Postal Code

6842 CV

Country

Netherlands

Facility Name

GSK Investigational Site

City

Den Haag

ZIP/Postal Code

2566 MJ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Doetinchem

ZIP/Postal Code

7009 BL

Country

Netherlands

Facility Name

GSK Investigational Site

City

Enschede

ZIP/Postal Code

7511JX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Etten-leur

ZIP/Postal Code

4872 LA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Groningen

ZIP/Postal Code

9721 SW

Country

Netherlands

Facility Name

GSK Investigational Site

City

Heerlen

ZIP/Postal Code

6419 PC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Hilversum

ZIP/Postal Code

1213 XZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Tilburg

ZIP/Postal Code

5042 AD

Country

Netherlands

Facility Name

GSK Investigational Site

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

Facility Name

GSK Investigational Site

City

Winterswijk

ZIP/Postal Code

7101 BN

Country

Netherlands

Facility Name

GSK Investigational Site

City

Zwijndrecht

ZIP/Postal Code

3331 LZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Aalesund

ZIP/Postal Code

N-6026

Country

Norway

Facility Name

GSK Investigational Site

City

Bergen

ZIP/Postal Code

5094

Country

Norway

Facility Name

GSK Investigational Site

City

Bodø

ZIP/Postal Code

N-8009

Country

Norway

Facility Name

GSK Investigational Site

City

Haugesund

ZIP/Postal Code

5507

Country

Norway

Facility Name

GSK Investigational Site

City

Moelv

ZIP/Postal Code

N-2390

Country

Norway

Facility Name

GSK Investigational Site

City

Nøtterøy

ZIP/Postal Code

3128

Country

Norway

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

0257 OSLO

Country

Norway

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

0514

Country

Norway

Facility Name

GSK Investigational Site

City

Porsgrunn

ZIP/Postal Code

N-3922

Country

Norway

Facility Name

GSK Investigational Site

City

Tønsberg

ZIP/Postal Code

3116

Country

Norway

Facility Name

GSK Investigational Site

City

Manila

ZIP/Postal Code

1003

Country

Philippines

Facility Name

GSK Investigational Site

City

Quezon City

ZIP/Postal Code

1101

Country

Philippines

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-402

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-221

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-826

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-950

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

50-043

Country

Poland

Facility Name

GSK Investigational Site

City

Abrantes

ZIP/Postal Code

2200 Abrantes

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1069-166

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1269-098 Lisboa

Country

Portugal

Facility Name

GSK Investigational Site

City

Porto

ZIP/Postal Code

4099-004

Country

Portugal

Facility Name

GSK Investigational Site

City

Porto

ZIP/Postal Code

4150-113 PORTO

Country

Portugal

Facility Name

GSK Investigational Site

City

S. Martinho do Bispo

ZIP/Postal Code

3040-316 Coimbra

Country

Portugal

Facility Name

GSK Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Santurce

ZIP/Postal Code

00907

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Arad

ZIP/Postal Code

310175

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

Country

Romania

Facility Name

GSK Investigational Site

City

Cluj-Napoca

Country

Romania

Facility Name

GSK Investigational Site

City

Iasi

Country

Romania

Facility Name

GSK Investigational Site

City

Timisoara

Country

Romania

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

105229

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

109472

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

117 837

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

125206

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Rostov-na-Donu

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint Petersburg

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Smolensk

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

813 69

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

GSK Investigational Site

City

Kosice

ZIP/Postal Code

041 66

Country

Slovakia

Facility Name

GSK Investigational Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

GSK Investigational Site

City

Skalica

ZIP/Postal Code

909 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Cape Town

ZIP/Postal Code

8001

Country

South Africa

Facility Name

GSK Investigational Site

City

Claremont

ZIP/Postal Code

7700

Country

South Africa

Facility Name

GSK Investigational Site

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

GSK Investigational Site

City

Sunninghill

ZIP/Postal Code

2157

Country

South Africa

Facility Name

GSK Investigational Site

City

Alava

ZIP/Postal Code

01004

Country

Spain

Facility Name

GSK Investigational Site

City

Alcázar de San Juan (Ciudad Real)

ZIP/Postal Code

13600

Country

Spain

Facility Name

GSK Investigational Site

City

Badajoz

ZIP/Postal Code

6080

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08221

Country

Spain

Facility Name

GSK Investigational Site

City

Burgos

ZIP/Postal Code

09005

Country

Spain

Facility Name

GSK Investigational Site

City

Ciudad Real

ZIP/Postal Code

13005

Country

Spain

Facility Name

GSK Investigational Site

City

Elche (Alicante)

ZIP/Postal Code

03202

Country

Spain

Facility Name

GSK Investigational Site

City

Gijon

ZIP/Postal Code

33394

Country

Spain

Facility Name

GSK Investigational Site

City

Guadalajara

ZIP/Postal Code

19002

Country

Spain

Facility Name

GSK Investigational Site

City

Jerez de la Frontera

ZIP/Postal Code

11407

Country

Spain

Facility Name

GSK Investigational Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

Langreo (Oviedo)

ZIP/Postal Code

33920

Country

Spain

Facility Name

GSK Investigational Site

City

Las Palmas De Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

GSK Investigational Site

City

Las Palmas

ZIP/Postal Code

35020

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28016

Country

Spain

Facility Name

GSK Investigational Site

City

Malaga

ZIP/Postal Code

29020

Country

Spain

Facility Name

GSK Investigational Site

City

Manacor (Palma de Mallorca)

Country

Spain

Facility Name

GSK Investigational Site

City

Marbella

ZIP/Postal Code

29600

Country

Spain

Facility Name

GSK Investigational Site

City

Mendaro, Guipuzcoa

ZIP/Postal Code

20850

Country

Spain

Facility Name

GSK Investigational Site

City

Merida

ZIP/Postal Code

6800

Country

Spain

Facility Name

GSK Investigational Site

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

GSK Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07014

Country

Spain

Facility Name

GSK Investigational Site

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

GSK Investigational Site

City

Pontevedra

ZIP/Postal Code

36071

Country

Spain

Facility Name

GSK Investigational Site

City

Sabadell (Barcelona)

ZIP/Postal Code

08208

Country

Spain

Facility Name

GSK Investigational Site

City

San Sebastian

ZIP/Postal Code

20012

Country

Spain

Facility Name

GSK Investigational Site

City

San Sebastián

ZIP/Postal Code

20014

Country

Spain

Facility Name

GSK Investigational Site

City

Santa Cruz de Tenerife

ZIP/Postal Code

38010

Country

Spain

Facility Name

GSK Investigational Site

City

Santander

ZIP/Postal Code

38008

Country

Spain

Facility Name

GSK Investigational Site

City

Santander

Country

Spain

Facility Name

GSK Investigational Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

GSK Investigational Site

City

Tortosa

ZIP/Postal Code

43500

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

GSK Investigational Site

City

Vigo (Pontevedra)

ZIP/Postal Code

30211

Country

Spain

Facility Name

GSK Investigational Site

City

Vigo/Pontevedra

ZIP/Postal Code

36200

Country

Spain

Facility Name

GSK Investigational Site

City

Vitoria

ZIP/Postal Code

01009

Country

Spain

Facility Name

GSK Investigational Site

City

Vizcaya

ZIP/Postal Code

48902

Country

Spain

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

GSK Investigational Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

GSK Investigational Site

City

Chiangmai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

GSK Investigational Site

City

Sousse

ZIP/Postal Code

4054

Country

Tunisia

Facility Name

GSK Investigational Site

City

Tunis

ZIP/Postal Code

1007

Country

Tunisia

Facility Name

GSK Investigational Site

City

Tunis

ZIP/Postal Code

1008

Country

Tunisia

Facility Name

GSK Investigational Site

City

Istanbul

ZIP/Postal Code

34303

Country

Turkey

Facility Name

GSK Investigational Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

GSK Investigational Site

City

Sıhhiye/Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

GSK Investigational Site

City

Swansea

State/Province

Glamorgan

ZIP/Postal Code

SA4 4NU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Buckshaw Village, Chorley

State/Province

Lancashire

ZIP/Postal Code

PR7 7NA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Edinburgh

State/Province

Midlothian

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX2 6PD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Chichester

State/Province

Sussex West

ZIP/Postal Code

PO19 4SE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Clydebank, Glasgow

ZIP/Postal Code

G81 2DR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Edgbaston, Birmingham

ZIP/Postal Code

B15 2SQ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M15 6SX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Waterloo, Liverpool

ZIP/Postal Code

L22 0LG

Country

United Kingdom

Facility Name

GSK Investigational Site

12. IPD Sharing Statement

Citations:

PubMed Identifier

21269736

Citation

Antonanzas F, Brenes F, Molero JM, Fernandez-Pro A, Huerta A, Palencia R, Cozar JM. [Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain]. Actas Urol Esp. 2011 Feb;35(2):65-71. doi: 10.1016/j.acuro.2010.11.008. Epub 2011 Jan 26. Spanish.

Results Reference

background

PubMed Identifier

19239460

Citation

Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int. 2009 Apr;103(7):919-26. doi: 10.1111/j.1464-410X.2009.08196.x. Epub 2009 Feb 23.

Results Reference

background

PubMed Identifier

21933326

Citation

Bjerklund Johansen TE, Baker TM, Black LK. Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the Combination of Avodart and Tamsulosin trial. BJU Int. 2012 Mar;109(5):731-8. doi: 10.1111/j.1464-410X.2011.10511.x. Epub 2011 Sep 20.

Results Reference

background

PubMed Identifier

19545384

Citation

Black L, Grove A, Morrill B. The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms. Health Qual Life Outcomes. 2009 Jun 19;7:55. doi: 10.1186/1477-7525-7-55.

Results Reference

background

PubMed Identifier

18813219

Citation

Chung BH, Roehrborn CG, Siami P, Major-Walker K, Morrill BB, Wilson TH, Montorsi F. Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH. Prostate Cancer Prostatic Dis. 2009;12(2):152-9. doi: 10.1038/pcan.2008.49. Epub 2008 Sep 23.

Results Reference

background

PubMed Identifier

19825505

Citation

Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19. Erratum In: Eur Urol. 2010 Nov;58(5):801.

Results Reference

background

PubMed Identifier

21093145

Citation

Roehrborn CG, Andriole GL, Wilson TH, Castro R, Rittmaster RS. Effect of dutasteride on prostate biopsy rates and the diagnosis of prostate cancer in men with lower urinary tract symptoms and enlarged prostates in the Combination of Avodart and Tamsulosin trial. Eur Urol. 2011 Feb;59(2):244-9. doi: 10.1016/j.eururo.2010.10.040. Epub 2010 Nov 4.

Results Reference

background

PubMed Identifier

21332630

Citation

Roehrborn CG, Barkin J, Siami P, Tubaro A, Wilson TH, Morrill BB, Gagnier RP. Clinical outcomes after combined therapy with dutasteride plus tamsulosin or either monotherapy in men with benign prostatic hyperplasia (BPH) by baseline characteristics: 4-year results from the randomized, double-blind Combination of Avodart and Tamsulosin (CombAT) trial. BJU Int. 2011 Mar;107(6):946-54. doi: 10.1111/j.1464-410X.2011.10124.x. Epub 2011 Feb 18.

Results Reference

background

PubMed Identifier

22425127

Citation

Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial. J Urol. 2012 May;187(5):1732-8. doi: 10.1016/j.juro.2011.12.083. Epub 2012 Mar 15.

Results Reference

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PubMed Identifier

19901936

Citation

Becher E, Roehrborn CG, Siami P, Gagnier RP, Wilson TH, Montorsi F. The effects of dutasteride, tamsulosin, and the combination on storage and voiding in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the Combination of Avodart and Tamsulosin study. Prostate Cancer Prostatic Dis. 2009;12(4):369-74. doi: 10.1038/pcan.2009.37. Epub 2009 Sep 1.

Results Reference

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PubMed Identifier

21348912

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Montorsi F, Roehrborn C, Garcia-Penit J, Borre M, Roeleveld TA, Alimi JC, Gagnier P, Wilson TH. The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study. BJU Int. 2011 May;107(9):1426-31. doi: 10.1111/j.1464-410X.2011.10129.x. Epub 2011 Feb 23.

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PubMed Identifier

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Montorsi F, Henkel T, Geboers A, Mirone V, Arrosagaray P, Morrill B, Black L. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. Int J Clin Pract. 2010 Jul;64(8):1042-51. doi: 10.1111/j.1742-1241.2010.02428.x. Epub 2010 May 7.

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Haillot O, Fraga A, Maciukiewicz P, Pushkar D, Tammela T, Hofner K, Chantada V, Gagnier P, Morrill B. The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):302-6. doi: 10.1038/pcan.2011.13. Epub 2011 Apr 19.

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PubMed Identifier

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Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21. Erratum In: J Urol. 2008 Sep;180(3):1191.

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Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

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Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

Prostatic Hyperplasia

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