Cholesterol and Pharmacogenetic Study | NCT00451828

Studies
Cholesterol and Pharmacogenetic Study

NCT00451828

Sponsor

UCSF Benioff Children's Hospital Oakland

Status

Completed

Last Update Posted

Oct 5, 2011Estimated

Enrollment

1,000Estimated

Phase

Phase 4

Conditions

Hyperlipidemia
Hypercholesterolemia
Coronary Heart Disease
Cardiovascular Disease

Interventions

Simvastatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Oct 2004Actual

Completion Date

Not provided

First Submitted Date

Mar 23, 2007

First Submission Date that Met QC Criteria

Mar 23, 2007

First Posted Date

Mar 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2011

Last Update Posted Date

Oct 5, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

UCSF Benioff Children's Hospital OaklandOTHER

Collaborators

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
San Francisco General Hospital	OTHER
University of California, Los Angeles	OTHER
Cedars-Sinai Medical Center

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Simvastatin	Drug	40mg/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Cholesterol		-2, 0, 4, 6 weeks
LDL Cholesterol		-2, 0, 4, 6 weeks
HDL Cholesterol		-2, 0, 4, 6 weeks
Triglycerides		-2, 0, 4, 6 weeks
C-reactive protein		-2, 0, 4, 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Total Cholesterol/HDL Cholesterol		-2, 0, 4, 6 weeks
Apolipoprotein B		-2, 0, 4, 6 weeks
Apolipoprotein AI

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald M Krauss, M.D.	UCSF Benioff Children's Hospital Oakland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco General Hospital		San Francisco	California	94110	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16516587	Background	Simon JA, Lin F, Hulley SB, Blanche PJ, Waters D, Shiboski S, Rotter JI, Nickerson DA, Yang H, Saad M, Krauss RM. Phenotypic predictors of response to simvastatin therapy among African-Americans and Caucasians: the Cholesterol and Pharmacogenetics (CAP) Study. Am J Cardiol. 2006 Mar 15;97(6):843-50. doi: 10.1016/j.amjcard.2005.09.134. Epub 2006 Jan 27.
39061094

ID	Term
D006949	Hyperlipidemias
D006937	Hypercholesterolemia
D003327	Coronary Disease
D002318	Cardiovascular Diseases

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic