Cholesterol and Pharmacogenetic Study

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of the CAP study was to determine genetic influences on efficacy of simvastatin treatment with regard to LDL cholesterol reduction and changes in other markers of cardiovascular disease risk.

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

Details

• Lead Sponsor: Children's Hospital & Research Center Oakland; UCSF Benioff Children's Hospital Oakland
• Collaborators: Cedars-Sinai Medical Center; Duke University; National Heart, Lung, and Blood Institute (NHLBI); San Francisco General Hospital; University of California, Los Angeles; University of Washington
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• at least 30 years of age

• Total Cholesterol between 160 to 400 mg/dl

• > 3 grandparents of African-American descent or > 3 grandparents of Caucasian descent

• serum triglycerides < 400 mg/dl

• fasting glucose < 126 mg/dl

Exclusion Criteria:

• Use of lipid-lowering medication

• Use of over-the-counter products containing sterol or stanol esters or fish oil

• Recent or planned change in dietary intake or weight change of more than 4.5 kg

• Use of corticosteroids, immunosuppressive drugs or drugs affecting the CYP3A4 system

• Known liver disease or elevated transaminase levels

• Elevated creatine phosphokinase levels > 10 times upper limits of normal

• Uncontrolled blood pressure, or diabetes mellitus

• Abnormal renal or thyroid function

• Current alcohol or drug abuse

• Major illness in the preceding three months

• Pregnancy

• Know intolerance to statins

• Racial ancestry other than African-American or Caucasian