Hypercholesterolaemia
Conditions
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.
Interventions
PROCEDUREEchographic measurements
PROCEDUREBlood samples
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in carotid IMT from baseline to month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to month 12 of carotid internal diameter (ID) | — |
| wall cross sectional area (WCSA); carotid arterial mass (AM) | — |
| pulse pressure (PP); cross sectional distensibility and compliance (DC and CC) | — |
| pulse wave velocity (PWV); Lipid profile | — |
Countries
Belgium, France, Netherlands
Outcome results
None listed