Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

Phase 3 Completed 1334 enrolled Astellas Pharma Europe B.V.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2010-01-11
Primary completion: 2011-03-01
Completion: 2011-03-01

Outcome

Met primary endpoint

registry Placebo vs FDC 0.4 mg/6 mg; p <0.001; Least Squares Mean Difference -1.6 (95% CI -2.4 to -0.9) NCT01018511 ↗

registry Placebo vs FDC 0.4 mg/6 mg; p <0.001; Least Squares Mean Difference -3.7 (95% CI -4.9 to -2.5) NCT01018511 ↗

Publications

Background van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tamsulosin	Other / unclassified	0.4 mg	—
Subject	Tamsulosin	Other / unclassified	6 mg	—
Subject	Tamsulosin	Other / unclassified	9 mg	—