Official Title: “A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Tamsulosin OCAS 0.4 mg Tablets, Once Daily on Nocturia, Compared to Placebo, in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2006

Intervention(s) in this Clinical Trial

• Drug: Tamsulosin OCAS
  • Adrenoceptor antagonist
• Drug: Placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Tamsulosin OCAS tablet
• Placebo Comparator: 2
  • Placebo tablet

Primary Measures

• The change from baseline to week 12 in mean number of nocturnal voids
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Diagnosed as having LUTS associated with BPH
• On average, at least 2 voids per night over the last week
• A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)

Exclusion Criteria:

• Subject is currently taking diuretics
• Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Director Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00379067

Study ID Number: 617-EC-006

ClinicalTrials.gov Identifier: NCT00379067

Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Link to results on ClinicalStudyResults.org