Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 9, 2005
Last updated: March 17, 2008
Last verified: March 2008
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.

Condition Intervention Phase
Procedure: Echographic measurements
Procedure: Blood samples
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean change in carotid IMT from baseline to month 12.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: January 2003
Study Completion Date: July 2006

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00163163

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00163163     History of Changes
Other Study ID Numbers: A2581051
Study First Received: September 9, 2005
Last Updated: March 17, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015