A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.
NCT00379067 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 882
Last updated 2014-10-10
Summary
Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg \& placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.
Conditions
- Benign Prostatic Hyperplasia
Interventions
- DRUG
-
Tamsulosin OCAS
Adrenoceptor antagonist
- DRUG
-
placebo
Sponsors & Collaborators
-
Astellas Pharma Europe Ltd.
collaborator INDUSTRY - collaborator INDUSTRY
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Use Central Contact · Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-10-31
- Primary Completion
- 2006-11-30
- Completion
- 2006-11-30
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