Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ahmad Slim
• Collaborator: GlaxoSmithKline
• Treatments: Fenofibrate; Rosiglitazone

Criteria

Inclusion criteria:

1. Fasting plasma glucose <100 mg/dl

2. Fasting LDL <160 mg/dl and Triglyceride <400 mg/dl.

Exclusion criteria:

1. Congestive heart failure

2. Evidence of renal impairment (serum creatinine> 1.4mg/dL)

3. Liver disease (ALT and/or AST above the upper level of normal)

4. Known diabetes mellitus or impaired fasting glucose (fasting glucose ≥ 100mg/dL)

5. LDL of ≥160mg/dL and/or triglycerides of ≥400mg/dL

6. Pregnant or breast feeding women

7. Prior history of an acute coronary syndrome, myocardial infarction or revascularization procedures in the past

8. Life-threatening disease with a survival prognosis <3 years

9. Inability to take rosiglitazone and/or fenofibrate

10. Already on statin therapy or have been on statin therapy in the last 3 months