The Association of Genetic Polymorphisms With Statin-Induced Myopathy.
Association Analysis Between Single Nucleotide Polymorphisms in Statin-Related Genes and The Incidence of Myopathy Among Statin-Treated Patients
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedOctober 25, 2007
October 1, 2007
October 24, 2007
October 24, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
genotype of specific genes
one day
Secondary Outcomes (1)
single nucleotide polymorphism
one day
Study Arms (1)
1,2
Group 1 for the patients with rhabdomyolysis Group 2 for the control without any myopathy
Interventions
Eligibility Criteria
National Taiwan University Hospital
You may qualify if:
- Clinical diagnosis of Rhabdomyolysis because of prescription with statins
You may not qualify if:
- Carnitine palmityl transferase ll deficiency
- McArdle disease
- Myoadenylate deaminase deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
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.
BACKGROUND
Biospecimen
whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yen-Hui Chen, PhD
National Taiwan Univesity College of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 25, 2007
Study Start
August 1, 2007
Study Completion
January 1, 2008
Last Updated
October 25, 2007
Record last verified: 2007-10