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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tadalafil | Small molecule | 2.5 mg | Oral |
| Subject | Tadalafil | Small molecule | 5 mg | Oral |