At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 612 enrolled
Drug / intervention
Tadalafil +2 moredrug
Likely dose
Not stated in 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 and Tamsulosin 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
In Brief
A Phase 3 clinical trial evaluating Tadalafil, Placebo, and 1 other intervention for Benign Prostatic Hyperplasia. Completed, enrolled 612 participants across 6 sites in 2 countries.
Detailed Summary
This study is a randomized, double-blind, placebo and tamsulosin-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 (BPH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesJapan, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedMar 2009
Primary CompletionJun 2010
TodayJul 2026
First PostedMar 13, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.3 years ago
Interventions
Tadalafildrug
by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
Placebodrug
PO, QD (30 min after meal) for 12 weeks
Tamsulosindrug
PO, QD (30 min after meal) for 12 weeks