Conditions: Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia
Keywords: Vesomni Solifenacin succinate EC905 Tamsulosin hydrochloride OCAS Treatment Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1067
Healthy volunteers: no

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.

Detailed description:
This is an open-label extension study following the double blind 905-CL-055 study

Arms:
arm 1: Participants who received at least one dose of open-label fixed dose combination (FDC) treatment

Interventions: intervention 1: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) intervention 2: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol document: