drugset
drugset / Trial / NCT01021332

Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms

NCT01021332 ↗

Phase 3 Completed 1067 enrolled Astellas Pharma Europe B.V.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-04-26
Primary completion
2011-12-14
Completion
2011-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Solifenacin Small molecule 6 mg Oral
Subject Solifenacin Small molecule 9 mg Oral
Subject Tamsulosin Other / unclassified 0.4 mg Oral

Indications

benign prostatic hyperplasia