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Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

Last updated on October 12, 2019

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Study Location
Pfizer Investigational Site
Afsnee Gent, , 9051 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolaemia
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Postmenopausal women defined as having Age =

- Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and = 6 weeks of diet

- Triglycerides =

- Informed, written consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00163163
Pfizer
Completed
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

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Descriptive Information
Brief Title  ICMJE Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Official Title  ICMJE Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)
Brief SummaryTo evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolaemia
Intervention  ICMJE
  • Procedure: Echographic measurements
  • Procedure: Blood samples
Study Arms  ICMJE Not Provided
Publications *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. doi: 10.1016/j.fertnstert.2011.09.010. Epub 2011 Oct 6.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2006
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163163
Other Study ID Numbers  ICMJE A2581051
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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