Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Phase 3
Completed
- Conditions
- Hypercholesterolaemia
- Registration Number
- NCT00163163
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
Inclusion Criteria
- Postmenopausal women defined as having Age =< 70 years with documented menopause
- Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet
- Triglycerides =< 4 g/l(4.52 mmol/l)
- Informed, written consent
Exclusion Criteria
- Age > 70 years
- Unconfirmed menopause
- Overall duration of treatment with any HMG-CoA Reductase inhibitor > 3 months within the last year
- Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization
- History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA
- CPK levels > 3 times upper limit of normal
- Body Mass Index >= 30
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean change in carotid IMT from baseline to month 12.
- Secondary Outcome Measures
Name Time Method pulse wave velocity (PWV); Lipid profile pulse pressure (PP); cross sectional distensibility and compliance (DC and CC) Mean change from baseline to month 12 of carotid internal diameter (ID) wall cross sectional area (WCSA); carotid arterial mass (AM)
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇳🇱VE Maastricht, Netherlands