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DNA Diagnostic System for Statin Safety and Efficacy (SIM)

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ClinicalTrials.gov Identifier: NCT00767130
Recruitment Status : Unknown
Verified October 2008 by Genomas, Inc.
Recruitment status was:  Recruiting
First Posted : October 6, 2008
Last Update Posted : October 6, 2008
Hartford Hospital
University of California, San Francisco
Cornell University
Information provided by:
Genomas, Inc

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.

Condition or disease
Hypercholesterolemia Myopathy

Detailed Description:
Statin efficacy in primary and secondary prevention of cardiovascular disease has led to increasingly aggressive usage and dosage of statins. Their main clinically relevant safety risk is statin-induced myopathy (SIM) evidenced as a constellation of neuromuscular side effects (NMSE) that include myalgias (muscle aches, cramps, weakness) and myositis (monitored by elevation of serum creatine kinase [CK] activity). NMSEs are disabling to 3-20% of patients on statins, require alteration of therapy, and reduce compliance. NMSEs vary in extent between drugs and from patient to patient. We will develop a novel product termed SIM PhyzioType™ system to provide clinicians with individualized information for each patient on the safest statin drug among atorvastatin, simvastatin, and rosuvastatin, the 3 most prescribed statins. The PhyzioType consists of a multi-SNP (single nucleotide polymorphism) ensemble that, interpreted with a biomathematical algorithm, predicts drug response. We have developed a prototype PhyzioType system incorporating predictive models for myalgia, serum CK activity, and LDLc reduction for atorvastatin and simvastatin patients. We will recruit to obtain 250 patients treated with each drug and use existing clinical records to characterize their NMSE and LDLc responses. We will use physiogenomic analysis to identify those SNPs that differentiate the risk of NMSEs among the 3 statins and combine them into the SIM PhyzioType system. This work will also contribute to the pharmacology of SIM and unravel new pharmaceutical targets. We will create and validate the SIM PhyzioType system with clinically useful prediction of NMSEs and potency for each of the 3 statins. In Phase III a prospective trial is planned for FDA approval of the SIM PhyzioType product.

Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: DNA Diagnostic System for Statin Safety and Efficacy
Study Start Date : January 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

receiving atorvastatin
receiving simvastatin
receiving rosuvastatin

Primary Outcome Measures :
  1. myopathy [ Time Frame: in response to statin therapy ]
  2. serum creatine kinase activity [ Time Frame: in response to statin therapy ]

Secondary Outcome Measures :
  1. LDL cholesterol [ Time Frame: in response to statin therapy ]

Biospecimen Retention:   Samples With DNA
DNA extracted from blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for hypercholesterolemia at Hartford Hospital, University of California-San Francisco, or the Rogosin Clinic at New York Presbyterian Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767130

Contact: Richard L. Seip, PhD 860-545-5005 rseip@harthosp.org

United States, California
University of California-San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Alan H.B. Wu, PhD    (415) 206-3540    wualan@labmed2.ucsf.edu   
Principal Investigator: Alan H.B. Wu, PhD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Richard L. Seip, PhD    860-545-5005    rseip@harthosp.org   
Principal Investigator: Paul D. Thompson, M.D.         
United States, New York
Rogosin Institute, New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: Chioma Okoro    212-702-9600 ext 105    cokoro@mail.rockefeller.edu   
Contact: Bruce Gordon, M.D.         
Principal Investigator: Bruce Gordon, M.D.         
Sponsors and Collaborators
Genomas, Inc
Hartford Hospital
University of California, San Francisco
Cornell University
Principal Investigator: Gualberto Ruano, MD, PhD Genomas, Inc

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gualberto Ruano/President, Genomas, Inc.
ClinicalTrials.gov Identifier: NCT00767130     History of Changes
Other Study ID Numbers: 1 R44 HL091697-01
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: October 6, 2008
Last Verified: October 2008

Keywords provided by Genomas, Inc:
single nucleotide polymorphisms, SNP, LDL cholesterol, statin myopathy, atorvastatin, simvastatin, rosuvastatin

Additional relevant MeSH terms:
Muscular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents