NCT00783094

Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Tadalafil 2.5 mg	oral, daily
DRUG	Tadalafil 5 mg	oral, daily
DRUG	Placebo	oral, daily

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-06-01
• Completion: 2010-04-01
• First posted: 2008-10-31
• Last updated: 2011-03-29
• Results posted: 2010-07-28

Locations

6 sites across 1 country: Japan