Conditions: Benign Prostatic Hyperplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 422
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks. arm 2: 5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks. arm 3: Placebo tablet taken by mouth once a day for 12 weeks.

Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.

Interventions: intervention 1: Tadalafil 2.5 mg intervention 2: Tadalafil 5 mg intervention 3: Placebo
Intervention descriptions: intervention 1: oral, daily intervention 2: oral, daily intervention 3: oral, daily

Protocol document: