drugset / Trial / NCT00783094

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

NCT00783094

Phase 2 Completed 422 enrolled Eli Lilly and Company
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Tadalafil Small molecule 2.5 mg Oral
Subject Tadalafil Small molecule 5 mg Oral