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Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00163163
First received: September 9, 2005
Last updated: March 17, 2008
Last verified: March 2008
History of Changes
  Purpose

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
Hypercholesterolaemia
 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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163163

  Hide Study Locations
Locations
Belgium
Pfizer Investigational Site
Afsnee Gent, Belgium, 9051
Pfizer Investigational Site
Assenede, Belgium, 9960
Pfizer Investigational Site
Brussels, Belgium, 1180
Pfizer Investigational Site
Bruxelles, Belgium, 1180
Pfizer Investigational Site
Bruxelles, Belgium, 1190
Pfizer Investigational Site
Bruxelles, Belgium, 1090
Pfizer Investigational Site
Bruxelles, Belgium, 1030
Pfizer Investigational Site
Bruxelles, Belgium, 1050
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
France
Pfizer Investigational Site
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 Grand Quevilly, France, 76120
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, 75008
Pfizer Investigational Site
Paris, France, 75016
Pfizer Investigational Site
Paris, France, 75017
Pfizer Investigational Site
Paris, France, 75012
Pfizer Investigational Site
Paris, France, 75015
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
Netherlands
Pfizer Investigational Site
Ed Voerendaal, Netherlands, 6367
Pfizer Investigational Site
En Vaals, Netherlands, 6291
Pfizer Investigational Site
Ve Maastricht, Netherlands, 6222
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013