At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,067 enrolled
Drug / intervention
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) +1 moredrug
Likely dose
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)from 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.
An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, 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 tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) and tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg) for Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia. Completed, enrolled 1,067 participants across 70 sites in 11 countries.
Detailed Summary
Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belarus, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Slovakia, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartApr 2010
Primary CompletionDec 2011
TodayJul 2026
First PostedNov 26, 2009
Enrollment StartApr 26, 2010
Primary CompletionDec 14, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.6 years ago
Interventions
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)drug
oral
tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)drug
oral