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Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

NCT01001767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-01-07

Study results available
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Summary

Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.

Conditions

Interventions

DRUG

Lovaza

Lovaza one gram twice a day for 24 weeks

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • The Campbell Foundation

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Grace McComsey, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001767 on ClinicalTrials.gov