A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Tamsulosin OCAS (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The change from baseline to week 12 in mean number of nocturnal voids
Secondary outcome: 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
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
7 Sites, Belgium
6 Sites, Czech Republic
4 sites, Denmark
4 Sites, Finland
13 Sites, France
11 Sites, Germany
5 Sites, Greece
6 Sites, Hungary
3 Sites, Ireland
13 Sites, Italy
7 Sites, Netherlands
4 Sites, Norway
6 Sites, Poland
4 Sites, Portugal
5 Sites, Russian Federation
8 Sites, Spain
5 Sites, Switzerland
8 Sites, United Kingdom
1 Site, United Kingdom
Additional Information
Starting date: October 2005
Ending date: November 2006
Last updated: January 8, 2008
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