A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)
- Registration Number
- NCT00644709
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of \<115 mg/dL
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
Inclusion Criteria
- Completion of base study
- Dyslipidemia and at high risk of CHD
Exclusion Criteria
- Impaired liver function
- Gastrointestinal disease that could limit drug absorption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A Atorvastatin -
- Primary Outcome Measures
Name Time Method Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL Week 52
- Secondary Outcome Measures
Name Time Method Adverse events and laboratory test changes Weeks 17, 34, and 52 Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly Week 52 LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study Baseline and Weeks 17, 34, and 52 Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study Week 52 Achievement of LDL-C target by diabetic patients Week 52 Achievement of LDL-C target Weeks 17 and 34
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Wingene, Belgium