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

This study has been completed.

First Received on September 19, 2006. Last Updated on July 9, 2008 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborators:	Astellas Pharma Europe BV Boehringer Ingelheim Pharmaceuticals
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00379067

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:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379067

Show 19 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Europe BV

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Director:

Use Central Contact

Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ

More Information

No publications provided

Responsible Party:	Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier:	NCT00379067 History of Changes
Other Study ID Numbers:	617-EC-006
Study First Received:	September 19, 2006
Last Updated:	July 9, 2008
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 - French Health Products Safety Agency 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 and Social Development of the Russian Federation Switzerland: Swissmedic

Keywords provided by Astellas Pharma Inc:

Benign Prostatic Hyperplasia
Nocturia
Actigraphy
Tamsulosin

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists

Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012