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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 72 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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 July 23, 2014