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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379067
• Other study ID #: 617-EC-006
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2006
• Last updated: October 8, 2014
• Start date: October 2005
• Est. completion date: November 2006

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesHungary: National Institute of PharmacyIreland: Irish Medicines BoardItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteePoland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSlovakia: State Institute for Drug ControlSpain: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNorway: Norwegian Medicines AgencyRussia: Ministry of Health of the Russian FederationSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin OCAS
Adrenoceptor antagonist
• Placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Europe Ltd., Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline to week 12 in mean number of nocturnal voids		12 weeks	No
Secondary	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		12 weeks	No

External Links

•   Link to Results on JAPIC - enter 140530 in the JapicCTI-RNo. field