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

This study has been completed.
Sponsor:
Collaborators:
Astellas Pharma Europe Ltd.
Boehringer Ingelheim
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00379067
First received: September 19, 2006
Last updated: October 8, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   45 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00379067     History of Changes
Other Study ID Numbers: 617-EC-006
Study First Received: September 19, 2006
Last Updated: October 8, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Slovakia: State Institute for Drug Control
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Norway: Norwegian Medicines Agency
Russia: Ministry of Health of the Russian Federation
Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on November 25, 2014