Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

Phase 2 Completed 222 enrolled Astellas Pharma Inc

RandomizedParallel-groupTriple-blindTreatment

Summary

A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

Timeline

Start: 2007-06
Primary completion: 2008-08
Completion: 2008-08

Outcome

Met primary endpoint

paper Both active treatment groups were noninferior to placebo at end of treatment (EOT) for P(det)Q(max) and Q(max). PMID 22831853 ↗

Publications

Results Kaplan SA, He W, Koltun WD, Cummings J, Schneider T, Fakhoury A. Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial. Eur Urol. 2013 Jan;63(1):158-65. doi: 10.1016/j.eururo.2012.07.003. Epub 2012 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Solifenacin	Small molecule	6 mg	Oral
Subject	Solifenacin	Small molecule	9 mg	Oral
Subject	Tamsulosin	Other / unclassified	0.4 mg	Oral