Cholesterol and Pharmacogenetic Study

Completed · Phase 4

Conditions studied: Hyperlipidemia, Hypercholesterolemia, Coronary Heart Disease, Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT00451828

Run by

UCSF Benioff Children's Hospital Oakland

People needed

1000

Starts

2002-03-01

Last updated by the study team

2011-10-05

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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