Status:
COMPLETED
Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH
Lead Sponsor:
RECORDATI GROUP
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE3
Brief Summary
A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the ...
Detailed Description
This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label p...
Eligibility Criteria
Inclusion
- Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia
Exclusion
- Medical conditions that would confound the efficacy evaluation
- Medical conditions in which it would be unsafe to use an alpha-blocker
- Use of concomitant drugs that would confound the efficacy evaluation
- Use of concomitant drugs that would be unsafe with this alpha-blocker
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
1228 Patients enrolled
Trial Details
Trial ID
NCT00359905
Start Date
May 1 2006
End Date
January 1 2008
Last Update
February 19 2009
Active Locations (1)
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1
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF