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Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)

NCT00819910 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-04-24

Study results available
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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.

Conditions

  • Hypertriglyceridemia in Type 4 Hyperlipidemia
  • Non Diabetic Subjects With Normoglycemia

Interventions

DRUG

Rosiglitazone

Rosiglitazone 8mg daily for 12 weeks

DRUG

Placebo (Rosiglitazone)

Placebo (Rosiglitazone) 8mg daily for 12 weeks

DRUG

Placebo (Fenofibrate)

Placebo (Fenofibrate) 145 mg daily for 12 weeks

DRUG

Fenofibrate

Fenofibrate 145 mg daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Ahmad m slim, MD · Brooke Army Medical Center

  • Laudino Castillo-rojas, MD · Brooke Army Medical Center

  • Jennifer N Slim, DO · Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

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 NCT00819910 on ClinicalTrials.gov