Benign Prostatic Hyperplasia in Taiwan
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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: NCT00941343 |
Recruitment Status
:
Completed
First Posted
: July 17, 2009
Last Update Posted
: March 30, 2010
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Sponsor:
Sanofi
Information provided by:
Sanofi
Tracking Information | ||||
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First Submitted Date ICMJE | July 16, 2009 | |||
First Posted Date ICMJE | July 17, 2009 | |||
Last Update Posted Date | March 30, 2010 | |||
Study Start Date ICMJE | September 2006 | |||
Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Male Sexual Health Questionnaire Ejaculation score (MSHQ) [ Time Frame: At week 24 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00941343 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Benign Prostatic Hyperplasia in Taiwan | |||
Official Title ICMJE | Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin | |||
Brief Summary | Primary Objective:
Secondary Objective:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostatic Diseases | |||
Intervention ICMJE | Drug: Alfuzosin (XATRAL® - SL770499)
One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed |
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Study Arms | Experimental: 1
XATRAL 10mg OD
Intervention: Drug: Alfuzosin (XATRAL® - SL770499) |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
362 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | September 2008 | |||
Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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Sex/Gender |
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Ages | 40 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00941343 | |||
Other Study ID Numbers ICMJE | ALFUS_L_01816 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Medical Affairs Study Director, sanofi-aventis | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | March 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |