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Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin (ECGPPA)
This study is currently recruiting participants.
Verified by Liuhuaqiao Hospital, September 2009
First Received: September 4, 2009   Last Updated: September 25, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Liuhuaqiao Hospital:

Primary Outcome Measures:
  • CYP3A genetic polymorphisms have a dominant role in atorvastatin pharmacokinetics in vivo and CYP3A4*1G polymorphism affects the CYP3A4 enzyme. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The pharmacokinetics of atorvastatin in Chinese with coronary heart disease. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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)
Intervention Details:
    Drug: Atorvastatin
    tablet, 20mg, single dose
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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973986

Contacts
Contact: He Baoxia, PhD +86-20-36653435 hbxberry@yahoo.com.cn

Locations
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    
Sponsors and Collaborators
Liuhuaqiao Hospital
Investigators
Study Director: Zhao Shujin, PhD Liuhuaqiao Hospital
  More Information

No publications provided

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

Keywords provided by Liuhuaqiao Hospital:
atorvastatin
genetic polymorphisms
coronary heart disease
pharmacokinetics
CYP3A

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010