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Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

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: NCT01001767
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : April 9, 2012
Last Update Posted : January 7, 2015
Sponsor:
Collaborators:
The Campbell Foundation
Case Western Reserve University
GlaxoSmithKline
Information provided by (Responsible Party):
Grace McComsey, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator)
Conditions HIV Infections
Heart Disease
Interventions Drug: Lovaza
Drug: Placebo
Enrollment 35
Recruitment Details From April 22, 2009 to September 1, 2009 35 individuals were enrolled and randomized. Participants were recruited from the Special Immunology Unit at University Hospitals Case Medical Center and from other HIV clinics in Cleveland, Ohio.
Pre-assignment Details No wash out, run-in or transition period required for this study.
Arm/Group Title Lovaza Placebo
Hide Arm/Group Description Lovaza 1 gram by mouth twice a day x 24 weeks Placebo capsule by mouth twice a day x 24 weeks
Period Title: Overall Study
Started 18 17
Completed 14 17
Not Completed 4 0
Reason Not Completed
no baseline study performed             1             0
Protocol Violation             1             0
Lost to Follow-up             1             0
Physician Decision             1             0
Arm/Group Title Lovaza Placebo Total
Hide Arm/Group Description Lovaza 1 gram by mouth twice a day x 24 weeks Placebo capsule by mouth twice a day x 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
17
 100.0%
35
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 35 participants
51
(47 to 53)
51
(49 to 54)
51
(48 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
18
 100.0%
17
 100.0%
35
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 17 participants 35 participants
18 17 35
1.Primary Outcome
Title Change in Flow Mediated Dilation (FMD) of the Brachial Artery
Hide Description 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.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized to have equal number in both groups
Arm/Group Title Lovaza Placebo
Hide Arm/Group Description:
Lovaza 1 gram by mouth twice a day x 24 weeks
Placebo capsule by mouth twice a day x 24 weeks
Overall Number of Participants Analyzed 14 17
Mean (Standard Deviation)
Unit of Measure: percent change
-0.13  (2.60) 1.47  (4.05)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lovaza Placebo
Hide Arm/Group Description Lovaza 1 gram by mouth twice a day x 24 weeks Placebo capsule by mouth twice a day x 24 weeks
All-Cause Mortality
Lovaza Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Lovaza Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Lovaza Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Small sample size may have precluded our ability to detect a small effect. Pill counts were used to monitor adherence. All participants were male.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grace McComsey, MC
Organization: University Hospitals Case Medical Center
Phone: 216-844-3607
EMail: mccomsey.grace@clevelandactu.org
Layout table for additonal information
Responsible Party: Grace McComsey, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01001767    
Other Study ID Numbers: AIDS 10-08-24
First Submitted: October 22, 2009
First Posted: October 27, 2009
Results First Submitted: March 12, 2012
Results First Posted: April 9, 2012
Last Update Posted: January 7, 2015