At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 610 enrolled
Drug / intervention
Tadalafil +1 moredrug
Likely dose
Tadalafil 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 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
In Brief
A Phase 3 clinical trial evaluating Tadalafil and Placebo for Benign Prostatic Hyperplasia. Completed, enrolled 610 participants across 17 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesJapan, South Korea
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartDec 2011
Primary CompletionOct 2012
TodayJul 2026
First PostedOct 26, 2011
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.7 years ago
Interventions
Tadalafildrug
5 mg (2 x 2.5-mg tablets), given once daily as oral tablet
Placebodrug
2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily.