NCT00861757

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

A Phase 3, 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 612 (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 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).

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Tadalafil	by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
DRUG	Placebo	PO, QD (30 min after meal) for 12 weeks
DRUG	Tamsulosin	PO, QD (30 min after meal) for 12 weeks

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-03-13
• Last updated: 2011-06-28
• Results posted: 2011-06-13

Locations

6 sites across 2 countries: Japan, Taiwan