Status:
COMPLETED
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE3
Brief Summary
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Detailed Description
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electro...
Eligibility Criteria
Inclusion
- Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.
Exclusion
- Medical conditions that would confound the efficacy evaluation.
- Medical conditions in which it would be unsafe to use an alpha-blocker.
- The use of concomitant drugs that would confound the efficacy evaluation.
- The use of concomitant drugs that would be unsafe with this alpha-blocker.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
661 Patients enrolled
Trial Details
Trial ID
NCT00224133
Start Date
September 1 2005
End Date
April 1 2007
Last Update
April 27 2010
Active Locations (79)
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1
Birmingham, Alabama, United States
2
Huntsville, Alabama, United States
3
Tucson, Arizona, United States
4
Anaheim, California, United States