Status:
COMPLETED
Cholesterol and Pharmacogenetic Study
Lead Sponsor:
UCSF Benioff Children's Hospital Oakland
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
San Francisco General Hospital
Conditions:
Hyperlipidemia
Hypercholesterolemia
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Despite widespread use of statin therapy for reducing risk of cardiovascular disease risk, there is considerable inter-individual variation in statin efficacy, and it would be desirable to identify ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00451828
Start Date
March 1 2002
Last Update
October 5 2011
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110