A Phase 4 interventional study of Simvastatin in Hyperlipidemia, Hypercholesterolemia and Coronary Heart Disease, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-05.
Sponsored by UCSF Benioff Children's Hospital Oakland · Phase 4, Interventional, and Prevention
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.
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.
839 studies on the registry are indexed under Hyperlipidemias; 107 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 88 across 707 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 55 studies on the registry; none are open to participants now.
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Exclusion Criteria:
40mg/day
Total Cholesterol
Time frame: -2, 0, 4, 6 weeks
LDL Cholesterol
Time frame: -2, 0, 4, 6 weeks
HDL Cholesterol
Time frame: -2, 0, 4, 6 weeks
Triglycerides
Time frame: -2, 0, 4, 6 weeks
C-reactive protein
Time frame: -2, 0, 4, 6 weeks
Total Cholesterol/HDL Cholesterol
Time frame: -2, 0, 4, 6 weeks
Apolipoprotein B
Time frame: -2, 0, 4, 6 weeks
Apolipoprotein AI
Time frame: -2, 0, 4, 6 weeks
Apolipoprotein CIII
Time frame: -2, 0, 4, 6 weeks
LDL Peak Particle size
Time frame: -2, 0, 4, 6 weeks
LDL Subfractions
Time frame: -2, 0, 4, 6 weeks
The record gives a start of Mar 2002 and a primary completion of Oct 2004. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Simvastatin
UCSF Benioff Children's Hospital Oakland