A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding. - Full Text View

Sponsors and Collaborators:	Astellas Pharma Inc 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 IV

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

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
1: Active Comparator Tamsulosin OCAS tablet	Drug: Tamsulosin OCAS Adrenoceptor antagonist
2: Placebo Comparator 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

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	617-EC-006
Study First Received:	September 19, 2006
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00379067 History of Changes
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: National Agency for Medicines; 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

Study placed in the following topic categories:

Neurotransmitter Agents
Hyperplasia
Nocturia
Adrenergic Agents
Prostatic Diseases

Prostatic Hyperplasia
Tamsulosin
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Genital Diseases, Male

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Genital Diseases, Male

Pharmacologic Actions
Hyperplasia
Pathologic Processes
Prostatic Hyperplasia
Therapeutic Uses
Tamsulosin
Adrenergic Antagonists

ClinicalTrials.gov processed this record on May 07, 2009