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Sponsors and Collaborators: |
Brooke Army Medical Center GlaxoSmithKline |
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Information provided by: | Brooke Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00819910 |
The design of the study will be randomized, double blind trial, which will examine the effects of Rosiglitazone on the fasting TG, HDL, HDL particle size, LDL, LDL particle size, and plasma concentrations of apolipoproteins A-I, A-II, and C-III, function 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 VLDL and HDL metabolism.
Condition | Intervention | Phase |
---|---|---|
Type 4 Hyperlipidemia Normoglycemia |
Drug: Rosiglitazone Drug: Placebo (Rosiglitazone) Drug: Placebo (Fenofibrate) Drug: Fenofibrate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL) |
Estimated Enrollment: | 80 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Double placebo of Fenofibrate and Rosiglitazone for 12 weeks
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Drug: Placebo (Rosiglitazone) Drug: Placebo (Fenofibrate) |
2: Active Comparator
Fenofibrate 145 mg daily for 12 weeks Placebo (rosiglitazone) for 12 weeks
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Drug: Placebo (Rosiglitazone)
Drug: Fenofibrate
Fenofibrate 145 mg daily for 12 weeks
|
3: Experimental
Rosiglitazone 8mg daily for 12 weeks Fenofibrate (placebo) for 12 weeks
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Drug: Rosiglitazone
Rosiglitazone 8mg daily for 12 weeks
Drug: Placebo (Fenofibrate)
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4: Experimental
Rosiglitazone 8mg and Fenofibrate 145 mg daily for 12 weeks
|
Drug: Rosiglitazone
Rosiglitazone 8mg daily for 12 weeks
Drug: Fenofibrate
Fenofibrate 145 mg daily for 12 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Contact: Ahmad M Slim, MD | 210-916-4717 | Ahmad.slim@us.army.mil |
Contact: Dorette PearceMoore, ANP | 210-916-4717 | Dorette.pearcemoore@amedd.army.mil |
United States, Texas | |
Brooke Army Medical Center | Recruiting |
San Antonio, Texas, United States, 78234 | |
Contact: Ahmad m slim, MD 210-916-4717 ahmad.slim@us.army.mil | |
Contact: Dorette Pearcemoore, ANP 210-916-4717 dorrette.pearcemoore@amedd.army.mil |
Principal Investigator: | Ahmad m slim, MD | Brooke Army Medical Center |
Study Chair: | Laudino Castillo-rojas, MD | Brooke Army Medical Center |
Study Chair: | Paul Garrett, MD | Brooke Army Medical Center |
Responsible Party: | Brooke Army Medical Center ( Ahmad Slim, MD, FACP, MAJOR, MC ) |
Study ID Numbers: | C.2007.122 |
Study First Received: | January 8, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819910 History of Changes |
Health Authority: | United States: Federal Government |
Type 4 hyperlipidemia Rosiglitazone Fenofibrate |
Antimetabolites Hypoglycemic Agents Metabolic Diseases Hyperlipidemias Antilipemic Agents |
Procetofen Rosiglitazone Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Physiological Effects of Drugs Procetofen |
Pharmacologic Actions Hypoglycemic Agents Therapeutic Uses Rosiglitazone Dyslipidemias Lipid Metabolism Disorders |