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
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Condition or disease | Intervention/treatment |
---|---|
Rhabdomyolysis Myopathy | Genetic: DNA |
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 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 |
Group/Cohort | Intervention/treatment |
---|---|
1,2
Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy
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Genetic: DNA
withdraw 5~10mL blood from vein only once during the whole design
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- genotype of specific genes [ Time Frame: one day ]
- single nucleotide polymorphism [ Time Frame: one day ]
Biospecimen Retention: Samples With DNA

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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 |
Inclusion Criteria:
- Clinical diagnosis of Rhabdomyolysis because of prescription with statins
Exclusion Criteria:
- Carnitine palmityl transferase ll deficiency
- McArdle disease
- Myoadenylate deaminase deficiency

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
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 |
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 |
Study Director: | Yen-Hui Chen, PhD | National Taiwan Univesity College of Medicine |
Publications:
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 |