Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin
Information source: Liuhuaqiao Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease
Intervention: Atorvastatin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Liuhuaqiao Hospital Official(s) and/or principal investigator(s):
Zhao Shujin, PhD, Study Director, Affiliation: Liuhuaqiao Hospital
Overall contact:
He Baoxia, PhD, Phone: +86-20-36653435, Email: hbxberry@yahoo.com.cn
Summary
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.
Clinical Details
Official title: Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease
Study design: Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: CYP3A genetic polymorphisms have a dominant role in atorvastatin pharmacokinetics in vivo and CYP3A4*1G polymorphism affects the CYP3A4 enzyme.
Secondary outcome: The pharmacokinetics of atorvastatin in Chinese with coronary heart disease.
Detailed description:
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
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must demonstrate their willingness to participate in the study and comply
with its procedures by signing a written informed consent.
- Subjects must be >=35 years and <=70 years of age.
- Subjects must have an LDL-C concentration >=2. 6 mmol/L and TC concentration >=4. 14
mmol/L
- Body mass index (BMI) must be within the range of 19 to 30 for patients.
- Subjects must have documented coronary heart disease with one or more of the
following features:
- Documented stable angina (with evidence of ischemia on exercise testing)
- History of myocardial infarction
- History of percutaneous coronary intervention (with or without stent placement)
- Documented history of unstable angina or non-Q wave myocardial infarction.
Exclusion Criteria:
- Diabetes and endocrine or metabolic disease.
- Congestive heart failure defined by New York Heart Association (NYHA) as Class III or
IV.
- Uncontrolled cardiac arrhythmia.
- Uncontrolled hypertension (Systolic BP >160 mm Hg and/or Diastolic BP >100 mmHg on
two consecutive measurements).
- Liver or kidney disease confirmed by abnormal lab values or function.
- Smokers who report cigarette use of more then 10 cigarette per day.
- Subjects who consume >2 alcoholic drinks a day. (A drink is: a can of beer, glass of
wine, or single measure of spirits).
- Known human immunodeficiency virus (HIV) positive.
- Cancer.
- Subjects who are on any of the following concomitant medications:
- Medications that are potent inhibitors of CYP3A, including cyclosporine,
itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin,
nefazodone, protease inhibitors,mibefradil and large amounts of grapefruit juice
(>1 quart/day).
- Lipid-lowering agent: niacin (>200 mg/day) taken within 5 weeks, fibric acid
derivatives taken within 8 weeks.
Locations and Contacts
He Baoxia, PhD, Phone: +86-20-36653435, Email: hbxberry@yahoo.com.cn
Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, Guangdong 510010, China; Recruiting
He Baoxia, PhD, Phone: +86-20-36653435, Email: hbxberry@yahoo.com.cn
Additional Information
Starting date: June 2009
Ending date: June 2010
Last updated: September 25, 2009
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