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

September 9, 2005
March 17, 2008
January 2003
Not Provided
Mean change in carotid IMT from baseline to month 12.
Same as current
Complete list of historical versions of study NCT00163163 on ClinicalTrials.gov Archive Site
  • 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
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
Not Provided
Not Provided
 
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypercholesterolaemia
  • Procedure: Echographic measurements
  • Procedure: Blood samples
Not Provided
Gompel A, Boutouyrie P, Joannides R, Christin-Maitre S, Kearny-Schwartz A, Kunz K, Laurent S, Boivin JM, Pannier B, Pornel B, Struijker-Boudier HA, Thuillez C, Van Bortel L, Zannad F, Pithois-Merli I, Jaillon P, Simon T. Association of menopause and hormone replacement therapy with large artery remodeling. Fertil Steril. 2011 Dec;96(6):1445-50. Epub 2011 Oct 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2006
Not Provided

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Netherlands
 
NCT00163163
A2581051
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP