Recruiting

DNA Diagnostic

Sponsor:

Genomas, Inc

Code:

NCT00767130

Conditions

Hypercholesterolemia

Myopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Lipitor®, Zocor®, and Crestor® are statin drugs commonly taken to lower cholesterol and prevent heart disease. Statins lower cholesterol by different amounts in different patients and sometimes statins cause muscle pain, cramps, or weakness. This study will examine genetic differences in the blood of patients taking statins to predict both how well the statins lower cholesterol, and whether muscle discomfort occurs. Finding such genetic connections is the key to developing genetic tests that might eventually help determine which statin is best for a patient. About 1000 people will be in the study.

Conditions

Hypercholesterolemia

Myopathy

Study ID

NCT00767130

Start date

Jan, 2007

Status verified date

Oct, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • receiving, or documented to have received in the past, any of the statins including atorvastatin, simvastatin, rosuvastatin treatment for hypercholesterolemia
  • chart-documented clinical record of having had, never having had, or possibly having had, statin-associated myopathy

Exclusion Criteria:

  • never having taken any statin medication

Study Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

1

receiving atorvastatin

2

receiving simvastatin

3

receiving rosuvastatin

Primary outcome measure

  • myopathy [ Time Frame: in response to statin therapy ]
  • serum creatine kinase activity [ Time Frame: in response to statin therapy ]

Central Contacts and Locations

Central contacts

Richard L. Seip, PhD

860-545-5005rseip@harthosp.org

Locations

University of California-San Francisco

Recruiting

San Francisco, California, United States, 94110

Contacts

Alan H.B. Wu, PhD

(415) 206-3540wualan@labmed2.ucsf.edu

Principal Investigator:

Alan H.B. Wu, PhD

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Richard L. Seip, PhD

860-545-5005rseip@harthosp.org

Principal Investigator:

Paul D. Thompson, M.D.

Rogosin Institute, New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10021

Contacts

Chioma Okoro

212-702-9600cokoro@mail.rockefeller.edu

Principal Investigator:

Bruce Gordon, M.D.

More Information

Sponsor

Genomas, Inc

Last update posted

Oct 6, 2008

Last verified

Oct, 2008

Keywords

  • single nucleotide polymorphisms, SNP, LDL cholesterol, statin myopathy, atorvastatin, simvastatin, rosuvastatin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genomas, Inc on 2008-10-06.