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

Eli Lilly and Company1 site in 1 country422 target enrollmentNovember 2008

ConditionsBenign Prostatic Hyperplasia

InterventionsTadalafil 2.5 mg Tadalafil 5 mg Placebo

DrugsTadalafil 2.5 mg Tadalafil 5 mg Placebo

Overview

Phase: Phase 2
Intervention: Tadalafil 2.5 mg
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Enrollment: 422
Locations: 1
Primary Endpoint: Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

April 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Eli Lilly and Company

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
•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
•History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit
•History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit
•Clinical evidence of prostate cancer at Visit
•Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit
•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
•Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.

Arms & Interventions

Tadalafil 2.5 milligrams (mg)

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.

Intervention: Tadalafil 2.5 mg

Tadalafil 5 mg

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.

Intervention: Tadalafil 5 mg

Placebo

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: Placebo

Outcomes

Primary Outcomes

Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint

Time Frame: Baseline, 12 weeks

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 Outcomes

Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint(Baseline, 12 weeks)
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint(Baseline, 12 weeks)
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint(Baseline, 12 weeks)
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint(Baseline, 12 weeks)
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint(Baseline, 12 weeks)
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement(Baseline, 12 weeks)
Number of Participants With Adverse Events During 12 Weeks of the Study(Baseline through 12 weeks)
Change From Baseline in Blood Pressure at 12-Week Endpoint(Baseline, 12 weeks)
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint(Baseline, 12 Weeks)
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint(Baseline, 12 weeks)
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint(Baseline, 12 weeks)
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint(Baseline, 54 weeks)
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint(Baseline, 54 weeks)
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint(Baseline, 54 weeks)
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint(Baseline, 54 weeks)
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint(Baseline, 54 weeks)
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint(Baseline, 54 weeks)
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment(End of 12 weeks of double-blind through 54 weeks)
Change From Baseline in Blood Pressure During at 54-Week Endpoint(Baseline, 54 weeks)
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint(Baseline, 54-weeks)
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint(Baseline, 54 weeks)
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint(Baseline, 54 weeks)