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Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

Primary Purpose

Benign Prostatic Hyperplasia

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Finasteride
Tamsulosin
Finasteride-matching placebo
Tamsulosin-matching placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

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

Inclusion Criteria:

  • Possess a clinical diagnosis of BPH.
  • Able to read, understand, and complete the study questionnaire.

Exclusion Criteria:

  • History or recurrent evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study.
  • History of malignancy ≤ 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, including prostate cancer of any duration, evidence or suspicion of prostate cancer on a previous biopsy.
  • History of prostatic surgery or other invasive procedures to treat BPH or history of bladder neck obstruction, bladder cancer, and/or pelvic irradiation, urinary incontinence, recurrent urinary tract infection, urethral stricture, or bacterial prostatitis.
  • History of acute urinary retention (ie, inability to fully empty bladder).
  • Had invasive urinary bladder procedures (ie, cystoscopy) within 7 days prior to screening.
  • Had phytotherapy within 2 weeks of screening and may need phytotherapy during the study.
  • History of low blood pressure (orthostatic hypotension, hypotension [supine blood pressure less than 90/70 mm Hg]), unstable angina, or a cardiovascular or cerebral vascular event (ie, transient ischemic attack [TIA], stroke) within the previous 3 months prior to enrollment, OR a history of dizziness, vertigo or any other typical signs and symptoms of low blood pressure.
  • Recent history (ie, within the past year) or active addiction, abuse, misuse of and/or dependence on drugs and/or alcohol.
  • Use of herbal therapies that may impact the study (eg, Saw Palmetto) within 2 weeks of screening and/or is predicted to need herbal therapies during the study. Individuals currently taking herbal therapies may be eligible for study if willing to complete a 2-week washout period.
  • Use of finasteride or a drug with a similar action during the 12 months prior to study screening. Individuals treated for short periods with 5-alpha reductase inhibitors (5ARIs) or drugs with antiandrogenic properties within 12 months of screening may be eligible for study.
  • Use of a non-approved (investigational) drug within the last 4 weeks prior to enrollment, or current participation in another clinical study.
  • Allergic or intolerant to finasteride and/or tamsulosin.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Arm Label

    Finasteride

    Tamsulosin

    Finasteride and Tamsulosin

    Arm Description

    Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.

    Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.

    Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in International Prostate Symptom Score (IPSS)
    The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.
    Percent Change From Baseline in Prostate Volume
    Prostate volume was assessed by trans-rectal ultrasound (TRUS).
    Number of Participants Who Experienced an Adverse Event
    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
    Number of Participants Who Discontinued Treatment Due to an Adverse Event
    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 13, 2012
    Last Updated
    July 30, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01534351
    Brief Title
    Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
    Official Title
    A Phase III, Randomized Clinical Trial to Study the Safety and Efficacy of MK-906 (Finasteride) and Tamsulosin Administered Either Alone or Concomitantly in Patients With Benign Prostatic Hyperplasia (BPH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Business Reasons
    Study Start Date
    August 1, 2013 (Actual)
    Primary Completion Date
    November 18, 2013 (Actual)
    Study Completion Date
    November 18, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is designed to compare safety and efficacy of monotherapy finasteride to combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from baseline on the International Prostate Symptoms Score (IPSS) and will be superior with respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as measured by percent change from baseline in prostate volume.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Finasteride
    Arm Type
    Experimental
    Arm Description
    Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
    Arm Title
    Tamsulosin
    Arm Type
    Active Comparator
    Arm Description
    Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
    Arm Title
    Finasteride and Tamsulosin
    Arm Type
    Experimental
    Arm Description
    Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
    Intervention Type
    Drug
    Intervention Name(s)
    Finasteride
    Other Intervention Name(s)
    Proscar®
    Intervention Description
    Finasteride 5 mg oral tablet taken once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin
    Other Intervention Name(s)
    Flomax®
    Intervention Description
    Tamsulosin 0.2 mg oral capsule taken once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Finasteride-matching placebo
    Intervention Description
    Matching placebo to finasteride 5 mg oral tablet taken once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin-matching placebo
    Intervention Description
    Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in International Prostate Symptom Score (IPSS)
    Description
    The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.
    Time Frame
    Baseline and Month 12
    Title
    Percent Change From Baseline in Prostate Volume
    Description
    Prostate volume was assessed by trans-rectal ultrasound (TRUS).
    Time Frame
    Baseline and Month 12
    Title
    Number of Participants Who Experienced an Adverse Event
    Description
    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
    Time Frame
    Up to 54 weeks
    Title
    Number of Participants Who Discontinued Treatment Due to an Adverse Event
    Description
    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
    Time Frame
    Up to 52 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Possess a clinical diagnosis of BPH. Able to read, understand, and complete the study questionnaire. Exclusion Criteria: History or recurrent evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study. History of malignancy ≤ 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, including prostate cancer of any duration, evidence or suspicion of prostate cancer on a previous biopsy. History of prostatic surgery or other invasive procedures to treat BPH or history of bladder neck obstruction, bladder cancer, and/or pelvic irradiation, urinary incontinence, recurrent urinary tract infection, urethral stricture, or bacterial prostatitis. History of acute urinary retention (ie, inability to fully empty bladder). Had invasive urinary bladder procedures (ie, cystoscopy) within 7 days prior to screening. Had phytotherapy within 2 weeks of screening and may need phytotherapy during the study. History of low blood pressure (orthostatic hypotension, hypotension [supine blood pressure less than 90/70 mm Hg]), unstable angina, or a cardiovascular or cerebral vascular event (ie, transient ischemic attack [TIA], stroke) within the previous 3 months prior to enrollment, OR a history of dizziness, vertigo or any other typical signs and symptoms of low blood pressure. Recent history (ie, within the past year) or active addiction, abuse, misuse of and/or dependence on drugs and/or alcohol. Use of herbal therapies that may impact the study (eg, Saw Palmetto) within 2 weeks of screening and/or is predicted to need herbal therapies during the study. Individuals currently taking herbal therapies may be eligible for study if willing to complete a 2-week washout period. Use of finasteride or a drug with a similar action during the 12 months prior to study screening. Individuals treated for short periods with 5-alpha reductase inhibitors (5ARIs) or drugs with antiandrogenic properties within 12 months of screening may be eligible for study. Use of a non-approved (investigational) drug within the last 4 weeks prior to enrollment, or current participation in another clinical study. Allergic or intolerant to finasteride and/or tamsulosin.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=0906A-149&kw=0906A-149&tab=access

    Learn more about this trial

    Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

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