A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.

Verified by: Astellas Pharma Inc, July 2008
First Received: September 19, 2006 | Last Updated: July 9, 2008 | Phase: Phase 4 | Start Date: October 2005
Overall Status: Completed | Estimated Enrollment: 882
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Astellas Pharma Inc Industry

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  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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