Status:
COMPLETED
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hypercholesterolaemia
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00163163
Start Date
January 1 2003
End Date
July 1 2006
Last Update
February 18 2021
Active Locations (69)
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1
Pfizer Investigational Site
Afsnee GENT, Belgium, 9051
2
Pfizer Investigational Site
Assenede, Belgium, 9960
3
Pfizer Investigational Site
Brussels, Belgium, 1030
4
Pfizer Investigational Site
Brussels, Belgium, 1050