NCT00451828

Cholesterol and Pharmacogenetic Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: UCSF Benioff Children's Hospital Oakland · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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.

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 markers that would be predictive of the magnitude of beneficial response. The effect of statin most strongly associated with improved clinical outcomes is reduction in LDL cholesterol. The CAP study was a six week non-randomized, open label study of simvastatin 40 mg/day in a group of 335 African-American and 609 Caucasian volunteer subjects. Measurements of plasma lipids and lipoproteins, as well as other markers of cardiovascular disease risk, were obtained at the screening and entry visits, and after four and six weeks of simvastatin treatment. Both baseline measurements and changes in response to simvastatin therapy are being used to test for associations with genetic polymorphisms. Significant findings are being replicated in other study cohorts.

Conditions

• Hyperlipidemia
• Hypercholesterolemia
• Coronary Heart Disease
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Simvastatin	40mg/day

Timeline

• Start date: 2002-03-01
• Primary completion: 2004-10-01
• First posted: 2007-03-26
• Last updated: 2011-10-05

Locations

1 site across 1 country: United States