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Sponsors and Collaborators: |
Genomas, Inc Hartford Hospital University of California, San Francisco Cornell University |
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Information provided by: | Genomas, Inc |
ClinicalTrials.gov Identifier: | NCT00767130 |
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 |
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Hypercholesterolemia Myopathy |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | DNA Diagnostic System for Statin Safety and Efficacy |
DNA extracted from blood samples
Estimated Enrollment: | 750 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
receiving atorvastatin
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2
receiving simvastatin
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3
receiving rosuvastatin
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients treated for hypercholesterolemia at Hartford Hospital, University of California-San Francisco, or the Rogosin Clinic at New York Presbyterian Hospital
Inclusion Criteria:
Exclusion Criteria:
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. |
Principal Investigator: | Gualberto Ruano, MD, PhD | Genomas, Inc |
Responsible Party: | Genomas, Inc. ( Gualberto Ruano/President ) |
Study ID Numbers: | 1 R44 HL091697-01 |
Study First Received: | October 2, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00767130 |
Health Authority: | United States: Institutional Review Board |
single nucleotide polymorphisms, SNP, LDL cholesterol, statin myopathy, atorvastatin, simvastatin, rosuvastatin |
Rosuvastatin Metabolic Diseases Hyperlipidemias Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases |
Simvastatin Metabolic disorder Hypercholesterolemia Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Nervous System Diseases |