The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months - Full Text View

Sponsored by:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00224133

Purpose

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

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Device: silodosin	Phase III

Drug Information available for: Silodosin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Safety [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in baseline score on the International Prostate Symptom Score [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment:	661
Study Start Date:	September 2005
Study Completion Date:	April 2007

Arms	Assigned Interventions
1: Experimental	Device: silodosin 8 mg daily

Detailed 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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224133

Show 79 Study Locations

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators

Study Director:

Lawrence Hill, Pharm D, RPh

Watson Pharmaceuticals

More Information

Responsible Party:	Watson ( Gary Hoel PhD Executive Director )
Study ID Numbers:	SI04011
Study First Received:	September 14, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00224133
Health Authority:	United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:

benign prostatic hyperplasia, alpha blocker

Study placed in the following topic categories:

Signs and Symptoms
Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009