At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,334 enrolled
Drug / intervention
Placebo tamsulosin hydrochloride OCAS 0.4 mg +5 moredrug
Likely dose
Placebo tamsulosin hydrochloride OCAS 0.4 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 Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
In Brief
A Phase 3 clinical trial evaluating Placebo tamsulosin hydrochloride OCAS 0.4 mg, Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg, and 4 other interventions for Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms. Completed, enrolled 1,334 participants across 118 sites in 13 countries.
Detailed Summary
Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belarus, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Russia, Slovakia, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartJan 2010
Primary CompletionMar 2011
TodayJul 2026
First PostedNov 23, 2009
Enrollment StartJan 11, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.6 years ago
Interventions
Placebo tamsulosin hydrochloride OCAS 0.4 mgdrug
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mgdrug
tablet
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mgdrug
tablet
tamsulosin hydrochloride OCAS 0.4 mgdrug
tablet
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)drug
tablet
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)drug
tablet