Status:
TERMINATED
Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)
Lead Sponsor:
Ahmad Slim
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia in Type 4 Hyperlipidemia
Non Diabetic Subjects With Normoglycemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 lipoprote...
Detailed Description
Treatment of patients with type 2 Diabetes Mellitus (DM) consists of reducing hyperglycemia through diet, exercise, oral drug therapy or insulin (1). The Thiazolidinedione (TZDs), which include Trogli...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Fasting plasma glucose \<100 mg/dl
- Fasting LDL \<160 mg/dl and Triglyceride \<400 mg/dl.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00819910
Start Date
September 1 2008
End Date
May 1 2010
Last Update
April 24 2014
Active Locations (1)
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1
Brooke Army Medical Center
San Antonio, Texas, United States, 78234