NCT01460342

Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 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: 610 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, randomized, double-blind, placebo-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.

Detailed description

Tadalafil is being investigated as a treatment for men with signs and symptoms of benign prostatic hyperplasia \[BPH; also referred to as urinary disturbance or BPH-LUTS (BPH-lower urinary tract symptoms)\] in Japan and overseas. Overseas studies and the Japanese dose-finding study LVIA (NCT00783094) identified tadalafil 5 mg once-daily as the recommended dose. The long-term safety and maintenance of effect was confirmed in the open-label extension of study LVIA. The risk-benefit profile was further studied in the Asian study LVHB (NCT00861757). This study, LVJF, is to confirm the efficacy and safety of tadalafil 5 mg once-daily in Asian men with BPH-LUTS.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Tadalafil	5 mg (2 x 2.5-mg tablets), given once daily as oral tablet
DRUG	Placebo	2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-10-26
• Last updated: 2013-09-25
• Results posted: 2013-09-25

Locations

17 sites across 2 countries: Japan, South Korea