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

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. Identifier: NCT00379067
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : October 10, 2014
Astellas Pharma Europe Ltd.
Boehringer Ingelheim
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Tamsulosin OCAS Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 882 participants
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
Study Start Date : October 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Tamsulosin OCAS tablet
Drug: Tamsulosin OCAS
Adrenoceptor antagonist

Placebo Comparator: 2
Placebo tablet
Drug: Placebo

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   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

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 identifier (NCT number): NCT00379067

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

Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00379067    
Other Study ID Numbers: 617-EC-006
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: October 10, 2014
Last Verified: October 2014
Keywords provided by Astellas Pharma Inc:
Benign Prostatic Hyperplasia
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
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