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

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224133
First received: September 14, 2005
Last updated: April 6, 2010
Last verified: April 2010
History of Changes
  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
 Drug: Silodosin
 Phase 3

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

Resource links provided by NLM:

Drug Information available for: Silodosin
U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.


Secondary Outcome Measures:
  • International Prostate Symptom Score (IPSS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 661
Study Start Date: September 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silodosin
Silodosin 8 mg per day with food
 Drug: Silodosin
8 mg daily
Other Name: Rapaflo

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.

All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

  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

Additional Information:
FDA approval summary and product label  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00224133     History of Changes
Other Study ID Numbers: SI04011
Study First Received: September 14, 2005
Results First Received: December 23, 2009
Last Updated: April 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
benign prostatic hyperplasia, alpha blocker

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013