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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379067
First Posted: September 21, 2006
Last Update Posted: October 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Astellas Pharma Europe Ltd.
Boehringer Ingelheim
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
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.

Condition Intervention Phase
Benign Prostatic Hyperplasia Drug: Tamsulosin OCAS Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The change from baseline to week 12 in mean number of nocturnal voids [ Time Frame: 12 weeks ]

Secondary Outcome 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 ]

Enrollment: 882
Study Start Date: October 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Tamsulosin OCAS tablet
Drug: Tamsulosin OCAS
Adrenoceptor antagonist
Placebo Comparator: 2
Placebo tablet
Drug: Placebo
placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379067


Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe Ltd.
Boehringer Ingelheim
Investigators
Study Director: Use Central Contact Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00379067     History of Changes
Other Study ID Numbers: 617-EC-006
First Submitted: September 19, 2006
First Posted: September 21, 2006
Last Update Posted: October 10, 2014
Last Verified: October 2014

Keywords provided by Astellas Pharma Inc:
Benign Prostatic Hyperplasia
Nocturia
Actigraphy
Tamsulosin

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents