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
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Sponsor:
Watson Pharmaceuticals
Information provided by:
Watson Pharmaceuticals
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Benign Prostatic Hyperplasia |
Intervention |
Drug: Silodosin |
Enrollment | 661 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 8 mg Silodosin Per Day With Food |
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[Not Specified] |
Period Title: Overall Study | |
Started | 661 |
Completed | 435 |
Not Completed | 226 |
Reason Not Completed | |
Adverse Event | 93 |
Protocol Violation | 6 |
Withdrawal by Subject | 33 |
Lack of Efficacy | 58 |
Lost to Follow-up | 21 |
Physician Decision | 1 |
Other | 14 |
Baseline Characteristics
Arm/Group Title | 8 mg Silodosin Per Day With Food | |
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[Not Specified] | |
Overall Number of Baseline Participants | 661 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 661 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
356 53.9%
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>=65 years |
305 46.1%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 661 participants | |
65.0 (7.79) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 661 participants | |
Female |
0 0.0%
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Male |
661 100.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 661 participants |
661 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Gary Hoel, RPh, PhD, Executive Director of Clinical Research |
Organization: | Watson Laboratories, Inc. |
Phone: | 801-588-6641 |
EMail: | gary.hoel@watson.com |
Responsible Party: | Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc. |
ClinicalTrials.gov Identifier: | NCT00224133 |
Other Study ID Numbers: |
SI04011 |
First Submitted: | September 14, 2005 |
First Posted: | September 22, 2005 |
Results First Submitted: | December 23, 2009 |
Results First Posted: | April 27, 2010 |
Last Update Posted: | April 27, 2010 |