Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hypertriglyceridemia in Type 4 Hyperlipidemia, Non Diabetic Subjects With Normoglycemia

In brief

The design of the study will be randomized, double blind trial, which will examine the effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and C-III as compared to Fenofibrate and placebo. This study will also assess the synergistic effect of Rosiglitazone and Fenofibrate on the same parameters. Data from this study will help clarify whether Rosiglitazone favorably impacts plasma lipid and lipoprotein concentrations through improving insulin sensitivity and glycemic control, or by directly influencing the synthesis of the apolipoproteins that are responsible for very-low-density lipoprotein (VLDL) and HDL metabolism.

Key facts

Study ID

NCT00819910

Run by

Ahmad Slim

People needed

41

Starts

2008-09-01

Expected to finish

2010-05-01

Last updated by the study team

2014-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Fasting plasma glucose <100 mg/dl
• Fasting LDL <160 mg/dl and Triglyceride <400 mg/dl.

You may not qualify if…

• Congestive heart failure
• Evidence of renal impairment (serum creatinine> 1.4mg/dL)
• Liver disease (ALT and/or AST above the upper level of normal)
• Known diabetes mellitus or impaired fasting glucose (fasting glucose ≥ 100mg/dL)
• LDL of ≥160mg/dL and/or triglycerides of ≥400mg/dL
• Pregnant or breast feeding women
• Prior history of an acute coronary syndrome, myocardial infarction or revascularization procedures in the past
• Life-threatening disease with a survival prognosis <3 years
• Inability to take rosiglitazone and/or fenofibrate
• Already on statin therapy or have been on statin therapy in the last 3 months

Where it is running

• Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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