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Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborators:
The Campbell Foundation
Case Western Reserve University
GlaxoSmithKline
Information provided by (Responsible Party):
Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01001767
First received: October 22, 2009
Last updated: May 14, 2012
Last verified: May 2012
Results First Received: March 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Conditions: HIV Infections
Heart Disease
Interventions: Drug: Lovaza
Drug: Placebo

  Participant Flow
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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
  Description
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  
NOT COMPLETED     4     0  
no baseline study performed                 1                 0  
Protocol Violation                 1                 0  
Lost to Follow-up                 1                 0  
Physician Decision                 1                 0  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  18     17     35  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     17     35  
>=65 years     0     0     0  
Age  
[units: years]
Median ( Inter-Quartile Range )
  51  
  ( 47 to 53 )  
  51  
  ( 49 to 54 )  
  51  
  ( 48 to 53 )  
Gender  
[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
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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
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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 Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01001767     History of Changes
Other Study ID Numbers: AIDS 10-08-24
Study First Received: October 22, 2009
Results First Received: March 12, 2012
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board