Conditions: Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms
Keywords: EC905 Solifenacin succinate Tamsulosin hydrochloride OCAS Treatment Benign Prostatic Hyperplasia Vesomni Lower Urinary Tract Symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1334
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet arm 2: Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet arm 3: Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet arm 4: Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Interventions: intervention 1: Placebo tamsulosin hydrochloride OCAS 0.4 mg intervention 2: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg intervention 3: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg intervention 4: tamsulosin hydrochloride OCAS 0.4 mg intervention 5: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) intervention 6: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Intervention descriptions: intervention 1: tablet intervention 2: tablet intervention 3: tablet intervention 4: tablet intervention 5: tablet intervention 6: tablet

Protocol document: