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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00224133
Other study ID # SI04011
Secondary ID
Status Completed
Phase Phase 3
First received September 14, 2005
Last updated April 6, 2010
Start date September 2005
Est. completion date April 2007

Study information

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

Clinical Trial Summary

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.


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, 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)


Recruitment information / eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Silodosin
8 mg daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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