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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
The Campbell Foundation
Case Western Reserve University
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No wash out, run-in or transition period required for this study.

Reporting Groups
Lovaza Lovaza 1 gram by mouth twice a day x 24 weeks
Placebo Placebo capsule by mouth twice a day x 24 weeks

Participant Flow:   Overall Study
    Lovaza   Placebo
STARTED   18   17 
COMPLETED   14   17 
no baseline study performed                1                0 
Protocol Violation                1                0 
Lost to Follow-up                1                0 
Physician Decision                1                0 

  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
Lovaza Lovaza 1 gram by mouth twice a day x 24 weeks
Placebo Placebo capsule by mouth twice a day x 24 weeks
Total Total of all reporting groups

Baseline Measures
   Lovaza   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   17   35 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   18   17   35 
>=65 years   0   0   0 
[Units: Years]
Median (Inter-Quartile Range)
 (47 to 53) 
 (49 to 54) 
 (48 to 53) 
[Units: Participants]
Female   0   0   0 
Male   18   17   35 
Region of Enrollment 
[Units: Participants]
United States   18   17   35 

  Outcome Measures

1.  Primary:   Change in Flow Mediated Dilation (FMD) of the Brachial Artery   [ Time Frame: baseline and week 24 ]

  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
Small sample size may have precluded our ability to detect a small effect. Pill counts were used to monitor adherence. All participants were male.

  More Information

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:  
Name/Title: Grace McComsey, MC
Organization: University Hospitals Case Medical Center
phone: 216-844-3607
e-mail: mccomsey.grace@clevelandactu.org

Publications of Results:

Responsible Party: Grace McComsey, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01001767     History of Changes
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