Clinical trial NCT00783094: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 422
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
measure: Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
timeFrame: Baseline, 12 weeks
measure: Number of Participants With Adverse Events During 12 Weeks of the Study
timeFrame: Baseline through 12 weeks
measure: Change From Baseline in Blood Pressure at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
timeFrame: Baseline, 12 Weeks
measure: Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
measure: Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
measure: Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
measure: Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
measure: Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
measure: Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
measure: Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
timeFrame: End of 12 weeks of double-blind through 54 weeks
measure: Change From Baseline in Blood Pressure During at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
measure: Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
timeFrame: Baseline, 54-weeks
measure: Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
measure: Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
timeFrame: Baseline, 54 weeks
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: 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
country: Japan
facility: 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
country: Japan
facility: 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
country: Japan
facility: 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
country: Japan
facility: 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
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: