The Association of Genetic Polymorphisms With Statin-Induced Myopathy.

October 24, 2007 updated by: National Taiwan University Hospital

Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tzung-Dau Wang, PhD
  • Phone Number: 5632 886-2-2312-3456
  • Email: tdwang@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yen-Hui Chen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

National Taiwan University Hospital

Description

Inclusion Criteria:

  • Clinical diagnosis of Rhabdomyolysis because of prescription with statins

Exclusion Criteria:

  • Carnitine palmityl transferase ll deficiency
  • McArdle disease
  • Myoadenylate deaminase deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
genotype of specific genes
Time Frame: one day
one day

Secondary Outcome Measures

Outcome Measure
Time Frame
single nucleotide polymorphism
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Anticipated)

January 1, 2008

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 24, 2007

First Posted (Estimate)

October 25, 2007

Study Record Updates

Last Update Posted (Estimate)

October 25, 2007

Last Update Submitted That Met QC Criteria

October 24, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200708077R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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