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Effect of Omacor on Triglycerides in HIV Infected Subjects

This study has been terminated.
(The study was discontinued prematurely on December 18 2008 due to slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598910
First Posted: January 23, 2008
Last Update Posted: March 30, 2009
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.
Information provided by:
Solvay Pharmaceuticals
January 11, 2008
January 23, 2008
March 30, 2009
August 2007
September 2008   (Final data collection date for primary outcome measure)
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo [ Time Frame: 12 weeks treatment ]
Percent change in serum triglycerides from baseline to treatment endpoint [ Time Frame: 12 weeks treatment ]
Complete list of historical versions of study NCT00598910 on ClinicalTrials.gov Archive Site
  • Absolute change in serum triglycerides [ Time Frame: 12 weeks ]
  • Absolute and percent change in cholesterol and cholesterol subfractions [ Time Frame: 12 weeks ]
  • Absolute and percent change in apolipoprotein A and B [ Time Frame: 12 weeks ]
Absolute change in serum triglycerides, absolute and percent change in cholesterol, cholesterol subfractions and in apolipoprotein A and B [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Effect of Omacor on Triglycerides in HIV Infected Subjects
A Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Investigate the Effect of Omacor (n-3 PUFA) on Lipid Parameters in HIV Infected Subjects Treated With HAART
Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hyper-Triglyceridemia
  • Drug: Omacor
    n-3 PUFA
  • Drug: Placebo
    Placebo
  • Experimental: A
    Intervention: Drug: Omacor
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Peters BS, Wierzbicki AS, Moyle G, Nair D, Brockmeyer N. The effect of a 12-week course of omega-3 polyunsaturated fatty acids on lipid parameters in hypertriglyceridemic adult HIV-infected patients undergoing HAART: a randomized, placebo-controlled pilot trial. Clin Ther. 2012 Jan;34(1):67-76. doi: 10.1016/j.clinthera.2011.12.001. Epub 2011 Dec 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
March 2009
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Triglycerides between 200 and 800
  • diagnosed HIV infection
  • following HAART therapy

Exclusion Criteria:

  • other malignant disease
  • not compliant
  • allergy against fish oil
  • soy or olive oil
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
 
NCT00598910
S185.4.001
2007-001921-86
No
Not Provided
Not Provided
Joachim Luszick, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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