The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224133
• Other study ID #: SI04011
• 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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

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

External Links

•   FDA approval summary and product label