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
|First Submitted Date||October 24, 2007|
|First Posted Date||October 25, 2007|
|Last Update Posted Date||October 25, 2007|
|Study Start Date||August 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||genotype of specific genes [ Time Frame: one day ]|
|Original Primary Outcome Measures||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures
||single nucleotide polymorphism [ Time Frame: one day ]|
|Original Secondary Outcome Measures||Same as current|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||The Association of Genetic Polymorphisms With Statin-Induced Myopathy.|
|Official Title||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 Design||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|
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||Unknown status|
|Original Estimated Enrollment||Same as current|
|Estimated Study Completion Date||January 2008|
|Primary Completion Date||Not Provided|
|Ages||21 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Taiwan|
|Removed Location Countries|
|Other Study ID Numbers||200708077R|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Taiwan University Hospital|
|PRS Account||National Taiwan University Hospital|
|Verification Date||October 2007|