The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
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|ClinicalTrials.gov Identifier: NCT00224133|
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 27, 2010
Last Update Posted : April 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Drug: Silodosin||Phase 3|
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, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.
All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||661 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
Silodosin 8 mg per day with food
8 mg daily
Other Name: Rapaflo
- Adverse Events [ Time Frame: 9 months ]All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
- International Prostate Symptom Score (IPSS) [ Time Frame: 9 months ]The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224133
|Study Director:||Lawrence Hill, Pharm D, RPh||Watson Pharmaceuticals|