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Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

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NCT00163163

Last updated on December 6, 2018
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Study Location
Pfizer Investigational Site
Afsnee Gent, , 9051 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolaemia
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Postmenopausal women defined as having Age =

- Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and = 6 weeks of diet

- Triglycerides =

- Informed, written consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00163163
Pfizer
Completed
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

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Pfizer Clinical Trials Contact Center

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[email protected]

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Hypercholesterolaemia
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
NCT00163163
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Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hypercholesterolaemia
  • Procedure: Echographic measurements
  • Procedure: Blood samples
Not Provided
Gompel A, Boutouyrie P, Joannides R, Christin-Maitre S, Kearny-Schwartz A, Kunz K, Laurent S, Boivin JM, Pannier B, Pornel B, Struijker-Boudier HA, Thuillez C, Van Bortel L, Zannad F, Pithois-Merli I, Jaillon P, Simon T. Association of menopause and hormone replacement therapy with large artery remodeling. Fertil Steril. 2011 Dec;96(6):1445-50. doi: 10.1016/j.fertnstert.2011.09.010. Epub 2011 Oct 6.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2006
Not Provided

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
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Netherlands
 
 
NCT00163163
A2581051
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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