The Association of Genetic Polymorphisms With Statin-Induced Myopathy.
Recruitment status was: Recruiting
|First Received Date ICMJE||October 24, 2007|
|Last Updated Date||October 24, 2007|
|Start Date ICMJE||August 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||genotype of specific genes [ Time Frame: one day ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||single nucleotide polymorphism [ Time Frame: one day ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Association of Genetic Polymorphisms With Statin-Induced Myopathy.|
|Official Title ICMJE||Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients|
|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.|
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Retrospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
|Sampling Method||Probability Sample|
|Study Population||National Taiwan University Hospital|
|Intervention ICMJE||Genetic: DNA
withdraw 5~10mL blood from vein only once during the whole design
Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy
Intervention: Genetic: DNA
|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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||150|
|Estimated Completion Date||January 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||21 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Taiwan|
|Removed Location Countries|
|NCT Number ICMJE||NCT00549029|
|Other Study ID Numbers ICMJE||200708077R|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Taiwan University Hospital|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Taiwan University Hospital|
|Verification Date||October 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP