Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

Viatris

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolaemia

Treatments: Procedure: Blood samples; Procedure: Echographic measurements

Study type: Interventional

Funder types: Industry

Identifiers

NCT00163163

A2581051

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind