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| Sponsor: | Liuhuaqiao Hospital |
|---|---|
| Information provided by: | Liuhuaqiao Hospital |
| ClinicalTrials.gov Identifier: | NCT00973986 |
Purpose
The aim of the study is to investigate the effects of CYP3A polymorphisms on the pharmacokinetics of Atorvastatin in Chinese subjects with coronary heart disease.
| Condition | Intervention |
|---|---|
|
Coronary Heart Disease |
Drug: Atorvastatin |
| Study Type: | Interventional |
| Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease |
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Large variability exists in the individual response to statins. CYP3A polymorphisms likely contribute to variable response to those drugs primarily metabolized by CYP3A including atorvastatin. CYP3A polymorphisms may have a dominant role in atorvastatin pharmacokinetics in vivo and dose adjustment based on CYP3A genotype may improve lipid-lowering response to atorvastatin.
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have documented coronary heart disease with one or more of the following features:
Exclusion Criteria:
Subjects who are on any of the following concomitant medications:
Contacts and Locations| Contact: He Baoxia, PhD | +86-20-36653435 | hbxberry@yahoo.com.cn |
| China, Guangdong | |
| Guangzhou General Hospital of Guangzhou Military Command | Recruiting |
| Guangzhou, Guangdong, China, 510010 | |
| Contact: He Baoxia, PhD +86-20-36653435 hbxberry@yahoo.com.cn | |
| Study Director: | Zhao Shujin, PhD | Liuhuaqiao Hospital |
More Information
| Responsible Party: | Guangzhou General Hospital of Guangzhou Military Command ( Department of pharmacy ) |
| Study ID Numbers: | YWLCSY-0900328, 08110831, GZJQZYY-003, ATR-01, GD080625, 20081001 |
| Study First Received: | September 4, 2009 |
| Last Updated: | September 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00973986 History of Changes |
| Health Authority: | China: Ethics Committee |
|
atorvastatin genetic polymorphisms coronary heart disease pharmacokinetics CYP3A |
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Arterial Occlusive Diseases Antimetabolites Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Antilipemic Agents Vascular Diseases Enzyme Inhibitors Arteriosclerosis |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Coronary Disease Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease Atorvastatin |