A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

Phase 2

Completed

• Conditions: Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Interventions: Drug: tamsulosin hydrochloride; Drug: Placebo; Drug: solifenacin succinate

• Registration Number: NCT00510406
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

Detailed Description

Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate

The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.

Other comparisons will be:

Placebo and combination treatment. Solifenacin monotherapy and combination treatment

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-07-31
• Study First Submitted QC: 2007-07-31
• Study First Posted: 2007-08-02
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 919

Inclusion Criteria

• male patients with LUTS associated with BPH diagnosed > 3 months
• IPSS score > 13
• voiding and storage symptoms
• maximum flow rate of > 4 mL/s and < 15 mL/s

Exclusion Criteria

• post void residual volume > 200 mL
• symptomatic urinary tract infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E	tamsulosin hydrochloride	-
A	Placebo	-
D	solifenacin succinate	-
C	solifenacin succinate	-
B	solifenacin succinate	-
F	tamsulosin hydrochloride	-
F	solifenacin succinate	-
G	tamsulosin hydrochloride	-
G	solifenacin succinate	-
H	solifenacin succinate	-
H	tamsulosin hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH	12 weeks

Secondary Outcome Measures

Name	Time	Method
Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride	12 weeks