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

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.

Timeline

Start

2008-11

Primary completion

2009-06

Completion

2010-04

Outcome

Missed primary endpoint

registry Tadalafil 2.5 mg vs Placebo; p = 0.201; Mean Difference (Final Values) -0.7 (95% CI -1.8 to 0.4) NCT00783094 ↗

registry Tadalafil 5 mg vs Placebo; p = 0.062; Mean Difference (Final Values) -1.1 (95% CI -2.2 to 0.1) NCT00783094 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tadalafil	Small molecule	2.5 mg	Oral
Subject	Tadalafil	Small molecule	5 mg	Oral

Indications