Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Afsnee GENT, Belgium, 9051
        • Pfizer Investigational Site
      • Assenede, Belgium, 9960
        • Pfizer Investigational Site
      • Brussels, Belgium, 1180
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1030
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1050
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1090
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1180
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1190
        • Pfizer Investigational Site
      • Ertvelde, Belgium, 9940
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Linkebeek, Belgium, 1630
        • Pfizer Investigational Site
      • Sint-niklaas, Belgium, 9100
        • Pfizer Investigational Site
      • Tielt, Belgium, 8700
        • Pfizer Investigational Site
      • Wetteren, Belgium, 9230
        • Pfizer Investigational Site
      • Wondelgem, Belgium, 9032
        • Pfizer Investigational Site
  • France
      • Achenheim, France, 67204
        • Pfizer Investigational Site
      • Ancerville, France, 55170
        • Pfizer Investigational Site
      • Augny, France, 57685
        • Pfizer Investigational Site
      • Bar Le Duc, France, 55000
        • Pfizer Investigational Site
      • Boersch, France, 67530
        • Pfizer Investigational Site
      • Bois-Colombes, France, 92220
        • Pfizer Investigational Site
      • Boissy Saint Leger, France, 94470
        • Pfizer Investigational Site
      • Bouzonville, France, 57320
        • Pfizer Investigational Site
      • Colombey-Les-Belles, France, 54170
        • Pfizer Investigational Site
      • Dammarie Les Lys, France, 77190
        • Pfizer Investigational Site
      • Docelles, France, 88460
        • Pfizer Investigational Site
      • Dourdan, France, 91410
        • Pfizer Investigational Site
      • Eckbolsheim, France, 67201
        • Pfizer Investigational Site
      • Epinay S/orge, France, 91360
        • Pfizer Investigational Site
      • Etampes, France, 91150
        • Pfizer Investigational Site
      • Frouard, France, 54390
        • Pfizer Investigational Site
      • Gambsheim, France, 67760
        • Pfizer Investigational Site
      • Haguenau, France, 67500
        • Pfizer Investigational Site
      • Kilstett, France, 67840
        • Pfizer Investigational Site
      • Laxou, France, 54520
        • Pfizer Investigational Site
      • Le Mesnil Esnard, France, 76240
        • Pfizer Investigational Site
      • Leuville Sur Orge, France, 91310
        • Pfizer Investigational Site
      • Lingolsheim, France, 67380
        • Pfizer Investigational Site
      • Longpont Sur Orge, France, 91310
        • Pfizer Investigational Site
      • Mars LA Tour, France, 54800
        • Pfizer Investigational Site
      • Metz, France, 57000
        • Pfizer Investigational Site
      • Moutiers, France, 54660
        • Pfizer Investigational Site
      • Nancy, France, 54100
        • Pfizer Investigational Site
      • Nancy, France, 54000
        • Pfizer Investigational Site
      • Nancy, France, 5400
        • Pfizer Investigational Site
      • Paris, France, 75015
        • Pfizer Investigational Site
      • Paris, France, 75008
        • Pfizer Investigational Site
      • Paris, France, 75012
        • Pfizer Investigational Site
      • Paris, France, 75016
        • Pfizer Investigational Site
      • Paris, France, 75017
        • Pfizer Investigational Site
      • Pont a Mousson, France, 54700
        • Pfizer Investigational Site
      • Pont-a-mousson, France, 54700
        • Pfizer Investigational Site
      • Pulnoy, France, 54420
        • Pfizer Investigational Site
      • Rouen, France, 76100
        • Pfizer Investigational Site
      • Sainte Genevieve Des Bois, France, 91700
        • Pfizer Investigational Site
      • Sauvigny, France, 55140
        • Pfizer Investigational Site
      • Savigny Sur Orge, France, 91600
        • Pfizer Investigational Site
      • Sotteville Les Rouen Cedex, France, 76308
        • Pfizer Investigational Site
      • Souffelweyersheim, France, 67460
        • Pfizer Investigational Site
      • St Max, France, 54130
        • Pfizer Investigational Site
      • Strasbourg, France, 67000
        • Pfizer Investigational Site
      • Strasbourg, France, 67200
        • Pfizer Investigational Site
      • Terville, France, 57180
        • Pfizer Investigational Site
      • Toul, France, 54200
        • Pfizer Investigational Site
      • Vandoeuvre, France, 54500
        • Pfizer Investigational Site
      • Vandoeuvre Les Nancy, France, 54500
        • Pfizer Investigational Site
      • Verdun, France, 55100
        • Pfizer Investigational Site
      • Vincennes, France, 94300
        • Pfizer Investigational Site
      • le Grand Quevilly, France, 76120
        • Pfizer Investigational Site
  • Netherlands
      • ED Voerendaal, Netherlands, 6367
        • Pfizer Investigational Site
      • EN Vaals, Netherlands, 6291
        • Pfizer Investigational Site
      • VE Maastricht, Netherlands, 6222
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean change in carotid IMT from baseline to month 12.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2581051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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