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Cholesterol and Pharmacogenetic Study (CAP)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
San Francisco General Hospital
University of California, Los Angeles
Cedars-Sinai Medical Center
University of Washington
Duke University
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00451828
First received: March 23, 2007
Last updated: October 4, 2011
Last verified: October 2011
History of Changes

March 23, 2007
October 4, 2011
March 2002
October 2004   (final data collection date for primary outcome measure)
  • Total Cholesterol [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • HDL Cholesterol [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Total Cholesterol
  • LDL Cholesterol
  • HDL Cholesterol
  • Triglycerides
  • C-reactive protein
Complete list of historical versions of study NCT00451828 on ClinicalTrials.gov Archive Site
  • Total Cholesterol/HDL Cholesterol [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein AI [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein CIII [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • LDL Peak Particle size [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • LDL Subfractions [ Time Frame: -2, 0, 4, 6 weeks ] [ Designated as safety issue: No ]
  • Total Cholesterol/HDL Cholesterol
  • Apolipoprotein B
  • Apolipoprotein AI
  • Apolipoprotein CIII
  • LDL Peak Particle size
  • LDL Subfractions
Not Provided
Not Provided
 
Cholesterol and Pharmacogenetic Study
Cholesterol and Pharmacogenetic Study

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hyperlipidemia
  • Hypercholesterolemia
  • Coronary Heart Disease
  • Cardiovascular Disease
Drug: Simvastatin
40mg/day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
Not Provided
October 2004   (final data collection date for primary outcome measure)

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
Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00451828
MM2277
Yes
Ronald M. Krauss, MD, Children's Hospital Oakland Research Institute
Children's Hospital & Research Center Oakland
  • National Heart, Lung, and Blood Institute (NHLBI)
  • San Francisco General Hospital
  • University of California, Los Angeles
  • Cedars-Sinai Medical Center
  • University of Washington
  • Duke University
Principal Investigator: Ronald M Krauss, M.D. Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP