Trial record 11 of 695 for:
Open Studies | "Muscular Diseases"
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
Recruitment status was Recruiting
Sponsor:
National Taiwan University Hospital
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
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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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549029
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
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.
| 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 |
ClinicalTrials.gov processed this record on September 27, 2016