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Sponsored by: |
Watson Pharmaceuticals |
Information provided by: | Watson Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00224120 |
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
Condition | Intervention | Phase |
Benign Prostatic Hyperplasia |
Drug: silodosin Other: Placebo |
Phase III |
ChemIDplus related topics: | Silodosin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia |
Enrollment: | 460 |
Study Start Date: | May 2005 |
Study Completion Date: | May 2006 |
Arms | Assigned Interventions |
1: Experimental
Silodosin
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Drug: silodosin
8 mg daily for 12 weeks
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2: Placebo Comparator
Placebo
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Other: Placebo
One capsule daily for 12 weeks
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This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 42 Study Locations |
Watson Pharmaceuticals |
Study Director: | Lawrence Hill, PharmD, RPh | Watson Pharmaceuticals |
Responsible Party: | Watson ( Gary Hoel PhD Executive Director ) |
Study ID Numbers: | SI04010 |
First Received: | September 14, 2005 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00224120 |
Health Authority: | United States: Food and Drug Administration |
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