Status:
COMPLETED
Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
Lead Sponsor:
Foundation Research, Florida
Collaborating Sponsors:
GlaxoSmithKline
Kos Pharmaceuticals
Conditions:
Metabolic Syndrome X
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome) are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL cholesterol; and sma...
Detailed Description
The Metabolic Syndrome is characterized by an atherogenic dyslipidemia consisting of hypertriglyceridemia, modest elevations of LDL cholesterol, low levels of HDL cholesterol, and LDL phenotype patter...
Eligibility Criteria
Inclusion
- Age \>= 18 years Fasting triglycerides \> 100 mg/dL Fasting plasma glucose 110-128 mg/dL Non-pattern A LDL phenotype
Exclusion
- Overt diabetes mellitus Current therapy with hypoglycemic agents Secondary causes of dyslipidemia (e.g. HRT, thyroid disease) Serum creatinine \> 2.5 mg/dL or nephrotic syndrome AST/ALT \> 3X upper limits of normal Known gallbladder disease History of gout or hyperuricemia History of peptic ulcer disease Hypersensitivity or intolerance to any of the study drugs Women who are pregnant or nursing
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00304993
Start Date
January 1 2001
End Date
February 1 2005
Last Update
March 21 2006
Active Locations (1)
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1
Foundation Research
St. Petersburg, Florida, United States, 33705