At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 422 enrolled
Drug / intervention
Tadalafil 2.5 mg +2 moredrug
Likely dose
Tadalafil 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing 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
In Brief
A Phase 2 clinical trial evaluating Tadalafil 2.5 mg, Tadalafil 5 mg, and 1 other intervention for Benign Prostatic Hyperplasia. Completed, enrolled 422 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartNov 2008
Primary CompletionJun 2009
Study CompletionApr 2010
TodayJul 2026
First PostedOct 31, 2008
Enrollment StartNov 1, 2008
Primary CompletionJun 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.7 years ago
Interventions
Tadalafil 2.5 mgdrug
oral, daily
Tadalafil 5 mgdrug
oral, daily
Placebodrug
oral, daily