A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
NCT00510406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 919
Last updated 2014-08-20
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.
Conditions
- Lower Urinary Tract Symptoms
- Prostatic Hyperplasia
Interventions
- DRUG
-
tamsulosin hydrochloride
Alphablocker
- DRUG
-
solifenacin succinate
antimuscarinic
- DRUG
-
Placebo
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Central Contact · Astellas Pharma Europe B.V.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2007-09-30
- Completion
- 2007-09-30
Countries
- Austria
- Czechia
- Denmark
- Finland
- France
- Germany
- Hungary
- Netherlands
- Norway
- Poland
- Portugal
- Russia
- Slovakia
- Spain
- Sweden
- United Kingdom
Study Locations
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