Status:
COMPLETED
A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Europe Ltd.
Boehringer Ingelheim
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Subject is currently taking diuretics
- Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
882 Patients enrolled
Trial Details
Trial ID
NCT00379067
Start Date
October 1 2005
End Date
November 1 2006
Last Update
October 10 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.