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The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

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ClinicalTrials.gov Identifier: NCT00549029
Recruitment Status : Unknown
Verified October 2007 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 25, 2007
Last Update Posted : October 25, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
To observe not only the distribution of single nucleotide polymorphism in genes related with pharmacodynamic and pharmacokinetics alteration of statins but also to analyze the correlation between these SNPs and the incidence of statins-induced myopathy.

Condition or disease Intervention/treatment
Rhabdomyolysis Myopathy Genetic: DNA

Detailed Description:

Statins are widely prescribed for the patients with hypercholesterolemia.

Though their efficacy in preventing cardiovascular events has been shown by a large number of clinical trials, myotoxic side effects including myopathy or even more severe,rhabdomyolysis are associated with the use of statins.

Because the incidence of myopathy is various among individuals,polymorphism in genes is supposed to be the main factor.

Due to single nucleotide polymorphism in related genes,level of uptake, clearance and metabolism of statins can be seriously different among individuals resulting in various occurrence of myopathy.

Therefore, analytical study in association between SNP of statins-related genes and the incidence of myopathy is such a critical research which can be applied into clinical fields.


Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients
Study Start Date : August 2007
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1,2
Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy
Genetic: DNA
withdraw 5~10mL blood from vein only once during the whole design


Outcome Measures

Primary Outcome Measures :
  1. genotype of specific genes [ Time Frame: one day ]

Secondary Outcome Measures :
  1. single nucleotide polymorphism [ Time Frame: one day ]

Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
National Taiwan University Hospital
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Rhabdomyolysis because of prescription with statins

Exclusion Criteria:

  • Carnitine palmityl transferase ll deficiency
  • McArdle disease
  • Myoadenylate deaminase deficiency
Contacts and Locations

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): NCT00549029


Contacts
Contact: Yen-Hui Chen, PhD 886-2-2312-3456 ext 8397 tcyhchen@ntu.edu.tw
Contact: Tzung-Dau Wang, PhD 886-2-2312-3456 ext 5632 tdwang@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yen-Hui Chen, PhD    886-2-2312-3456 ext 8397    tcyhchen@ntu.edu.tw   
Contact: Tzung-Dau Wang, PhD    886-2-2312-3456 ext 5632    tdwang@ntu.edu.tw   
Principal Investigator: Yen-Hui Chen, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Yen-Hui Chen, PhD National Taiwan Univesity College of Medicine
More Information

Publications:
Jisun Oh, et al. Genetic determinants of statin intolerance. Lipid in Health and Disease 2007;6(7). Wei Zhang, et al. Role of BCRP 421C>A polymorphism on rosuvastatin pharmacokinetics in healthy Chinese males. Clinica Chimica Acta 2006;373:99-103. Mikko Niemi, et al. Association of genetic polymorphism in ABCC2 with hepatic multidrug resistance-associated protein 2 expression and pravastatin pharmacokinetics. Pharmacogenetics and Genomics 2006;16:801-808. Andre' BM, et al. Association of polymorphism in the cytochrome CYP2D6 and the efficacy and tolerability of simvastatin. Clin Pharmacol Ther 2001;70:546-551. K. Morimoto, et al. OATP-C(OATPO1B1)15 IS ASSOCIATED WITH LESTEROLEMIC PATIENTS. CLINICAL PHARMACOLOGY THERAPEUTICS 2005;77(2). K. Morimoto, et al. CANDIDATE OF GENETIC MARKERS FOR STATIN-INDUCED MYOPATHY IN JAPANESE PATIENTS WITH HYPERCHOLESTEROLEMIA. Drug Metabolism Reviews 2005;37(4):345.

ClinicalTrials.gov Identifier: NCT00549029     History of Changes
Other Study ID Numbers: 200708077R
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 2007

Keywords provided by National Taiwan University Hospital:
muscle disorder
statins
creatine kinase

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