The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2007 by National Taiwan University Hospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT00549029

First received: October 24, 2007

Last updated: NA

Last verified: October 2007

History: No changes posted

Purpose

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	Intervention
Rhabdomyolysis Myopathy	Genetic: DNA


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Genes and Gene Therapy Muscle Disorders Statins

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

genotype of specific genes [ Time Frame: one day ]

Secondary Outcome Measures:

single nucleotide polymorphism [ Time Frame: one day ]

Biospecimen Retention: Samples With DNA

whole blood


Estimated Enrollment:	150
Study Start Date:	August 2007
Estimated Study Completion Date:	January 2008

Groups/Cohorts	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	October 24, 2007
Last Updated:	October 24, 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

ClinicalTrials.gov processed this record on July 21, 2017

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