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

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ClinicalTrials.gov Identifier: NCT00224133
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 27, 2010
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:
Watson Pharmaceuticals

Study Description
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Brief Summary:
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Silodosin Phase 3

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)


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 661 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Silodosin
Silodosin 8 mg per day with food
 Drug: Silodosin
8 mg daily
Other Name: Rapaflo


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 9 months ]
    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 :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: 9 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224133


  Show 79 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Lawrence Hill, Pharm D, RPh Watson Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Publications of Results:

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
First Posted: September 22, 2005    Key Record Dates
Results First Posted: April 27, 2010
Last Update Posted: April 27, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Silodosin
Adrenergic alpha-1 Receptor Antagonists
 Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents