We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00224133
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 27, 2010
Last Update Posted : April 27, 2010
Information provided by:
Watson Pharmaceuticals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Benign Prostatic Hyperplasia
Intervention: Drug: Silodosin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
8 mg Silodosin Per Day With Food No text entered.

Participant Flow:   Overall Study
    8 mg Silodosin Per Day With Food
STARTED   661 
Adverse Event                93 
Protocol Violation                6 
Withdrawal by Subject                33 
Lack of Efficacy                58 
Lost to Follow-up                21 
Physician Decision                1 
Not specified                14 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
8 mg Silodosin Per Day With Food No text entered.

Baseline Measures
   8 mg Silodosin Per Day With Food 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   356 
>=65 years   305 
[Units: Years]
Mean (Standard Deviation)
 65.0  (7.79) 
[Units: Participants]
Female   0 
Male   661 
Region of Enrollment 
[Units: Participants]
United States   661 

  Outcome Measures

1.  Primary:   Adverse Events   [ Time Frame: 9 months ]

2.  Secondary:   International Prostate Symptom Score (IPSS)   [ Time Frame: 9 months ]
Results not yet reported.   Anticipated Reporting Date:   03/2010  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Gary Hoel, RPh, PhD, Executive Director of Clinical Research
Organization: Watson Laboratories, Inc.
phone: 801-588-6641
e-mail: gary.hoel@watson.com

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 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