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

This study has been completed.
Information provided by:
Watson Pharmaceuticals Identifier:
First received: September 14, 2005
Last updated: April 6, 2010
Last verified: April 2010
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:

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)


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00224133

  Show 79 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Study Director: Lawrence Hill, Pharm D, RPh Watson Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc. 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
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents processed this record on April 27, 2016