Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Phase 3 Completed 612 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).

Timeline

Start: 2009-03
Primary completion: 2010-06
Completion: 2010-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tadalafil	Small molecule	2.5 mg	Oral
Subject	Tadalafil	Small molecule	5 mg	Oral
Comparator	Tamsulosin	Other / unclassified	0.2 mg	Oral

Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Summary

Timeline

Drugs

Indications