Benign Prostatic Hyperplasia Clinical Trial
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
Verified date | April 2010 |
Source | Watson Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Status | Completed |
Enrollment | 661 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010. Exclusion Criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Watson Pharmaceuticals |
United States,
Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318-22. doi: 10.1016/j.urology.2009.06.072. Epub 2009 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events. | 9 months | Yes |
Secondary | International Prostate Symptom Score (IPSS) | 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. | 9 months | No |
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