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OpenTrials
Completed

NCT Number: NCT00163163

Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

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.

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Afsnee GENT, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echographic measurements

Procedure

Blood samples

Procedure

Primary outcomes

  1. Mean change in carotid IMT from baseline to month 12.

Secondary outcomes

  1. Mean change from baseline to month 12 of carotid internal diameter (ID)

  2. wall cross sectional area (WCSA); carotid arterial mass (AM)

  3. pulse pressure (PP); cross sectional distensibility and compliance (DC and CC)

  4. pulse wave velocity (PWV); Lipid profile

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)

Important dates

Study start
2003
Study completion
2006
First posted
Sep 13, 2005
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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