clinical trial · NCT01021332
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Astellas Pharma Europe B.V.·phase3·completed·n = 1,067
Lower Urinary Tract SymptomsBenign Prostatic Hyperplasiatamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
brief 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.
started
Apr 26, 2010
primary completion
Dec 14, 2011
completion
Dec 14, 2011
last updated
Dec 3, 2024
detailed description
This is an open-label extension study following the double blind 905-CL-055 study
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol