Back to resultsStudy of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Tadalafil 2.5 mg
Tadalafil 5 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
- Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
- Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.
Exclusion Criteria:
- Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
- History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
- History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
- Clinical evidence of prostate cancer at Visit 1.
- Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
- History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
- History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
- Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Tadalafil 2.5 milligrams (mg)
Tadalafil 5 mg
Placebo
Arm Description
2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Placebo tablet taken by mouth once a day for 12 weeks. Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Secondary Outcome Measures
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.
Number of Participants With Adverse Events During 12 Weeks of the Study
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Change From Baseline in Blood Pressure at 12-Week Endpoint
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Change From Baseline in Blood Pressure During at 54-Week Endpoint
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
Post residual volume (PVR) is measured by ultrasound at regular intervals.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00783094
Brief Title
Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
422 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tadalafil 2.5 milligrams (mg)
Arm Type
Experimental
Arm Description
2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Arm Title
Tadalafil 5 mg
Arm Type
Experimental
Arm Description
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Intervention Type
Drug
Intervention Name(s)
Tadalafil 2.5 mg
Other Intervention Name(s)
LY450190, Cialis
Intervention Description
oral, daily
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5 mg
Other Intervention Name(s)
LY450190, Cialis
Intervention Description
oral, daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral, daily
Primary Outcome Measure Information:
Title
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
Description
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
Description
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
Description
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Description
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
Description
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
Description
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Time Frame
Baseline, 12 weeks
Title
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Description
Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.
Time Frame
Baseline, 12 weeks
Title
Number of Participants With Adverse Events During 12 Weeks of the Study
Description
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Time Frame
Baseline through 12 weeks
Title
Change From Baseline in Blood Pressure at 12-Week Endpoint
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Description
Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
Description
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
Description
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
Description
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
Description
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
Description
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
Description
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
Description
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Time Frame
Baseline, 54 weeks
Title
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
Description
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Time Frame
End of 12 weeks of double-blind through 54 weeks
Title
Change From Baseline in Blood Pressure During at 54-Week Endpoint
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
Time Frame
Baseline, 54-weeks
Title
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Description
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Time Frame
Baseline, 54 weeks
Title
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
Description
Post residual volume (PVR) is measured by ultrasound at regular intervals.
Time Frame
Baseline, 54 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.
Exclusion Criteria:
Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Chiba
ZIP/Postal Code
274-0825
Country
Japan
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Hiroshima
ZIP/Postal Code
730-0013
Country
Japan
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Kanagawa
ZIP/Postal Code
226-0025
Country
Japan
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Kyoto
ZIP/Postal Code
607-8085
Country
Japan
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Osaka
ZIP/Postal Code
561-0832
Country
Japan
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Tokyo
ZIP/Postal Code
150-0002
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
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