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Study Description

The Cholesterol and Pharmacogenetics Study was a 6-week open label, non-randomized study of 40mg/day simvastatin treatment in 944 African-American and Caucasian men and women. Plasma lipid and lipoprotein were measured on two occasions prior to treatment and at 4 and 6 weeks of treatment. The study was designed to test for genetic associations to baseline measurements and changes in response to simvastatin treatment.

Whole genome genotyping was performed on 592 Caucasians CAP study participants in two stages. In Stage 1, 304 were genotyped for 314,621 SNPs to tag for common genomic variation. In Stage 2, 290 subjects were genotyped, which included 280 subjects genotyped for 620,901 SNPs. Two samples were excluded due to gender discrepancies.

  • Study Type: Clinical Trial
  • Number of study subjects that have individual level data available through Authorized Access: 597

Authorized Access
Publicly Available Data (Public ftp)

Connect to the public download site. The site contains release notes and manifests. If available, the site also contains data dictionaries, variable summaries, documents, and truncated analyses.

Study Inclusion/Exclusion Criteria

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

Molecular Data
TypeSourcePlatformNumber of Oligos/SNPsSNP Batch IdComment
Whole Genome Genotyping Illumina HumanHap300v1.1 317503 33879
Study History

The trial was conducted between March 2002 and October 2004.

Selected publications
Diseases/Traits Related to Study (MESH terms)
Authorized Data Access Requests
Study Attribution