Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
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|ClinicalTrials.gov Identifier: NCT01001767|
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : April 9, 2012
Last Update Posted : January 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Heart Disease||Drug: Lovaza Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||June 2010|
Active Comparator: Lovaza
Lovaza 1 gram by mouth twice a day for 24 weeks.
Lovaza one gram twice a day for 24 weeks
Other Name: Omega-3 fatty acid
Placebo Comparator: Placebo
Placebo capsule by mouth twice a day x 24 weeks.
- Change in Flow Mediated Dilation (FMD) of the Brachial Artery [ Time Frame: baseline and week 24 ]Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.
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): NCT01001767
|United States, Ohio|
|University Hospitals of Cleveland Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Grace McComsey, MD||University Hospitals Cleveland Medical Center|