Effect of Crestor on Lipoprotein Metabolism in Humans

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this research is to understand how Crestor can effectively reduce the levels of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will facilitate the rate of removal of LDL from the blood. At the higher dose, the increased potency of Crestor is explained by a reduction in the production of LDL by the liver.

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

Details

• Lead Sponsor: Atlanta Research and Education Foundation; Foundation for Atlanta Veterans Education and Research, Inc.
• Collaborator: AstraZeneca
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• TG between 200 and 400 mg/dL

• LDLc between 160 and 250 mg/dL

• HDLc between 30 and 50 mg/dL for men and 40-65 mg/dL for women

• Lp(a) less than 30 mg/dL

• Age between 50 and 75 years

Exclusion Criteria:

• current lipid-lowering therapy,

• primary hypertriglyceridemia (TG>400 mg/dL),

• High HDL (HDL>70),

• high Lp(a), greater than 30 mg/dL

• presence of beta-VLDL on agarose electrophoresis,

• current use of immunosuppressive agents,

• hormone replacement therapy for women

• history of cancer, active liver disease or hepatic dysfunction (AST or ALT 1.5 x ULN (Upper Limit of Normal),

• excessive consumption of alcohol, and recent history of drug abuse.