The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

The recruitment status of this study is unknown because the information has not been verified recently.
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:


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
Genders Eligible for Study:   Both
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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00549029     History of Changes
Other Study ID Numbers: 200708077R
Study First Received: October 24, 2007
Last Updated: October 24, 2007
Health Authority: Taiwan: Department of Health

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
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014