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Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

Primary Purpose

Hypercholesterolaemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Echographic measurements
Blood samples
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolaemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00163163
Brief Title
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Official Title
Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Echographic measurements
Intervention Type
Procedure
Intervention Name(s)
Blood samples
Primary Outcome Measure Information:
Title
Mean change in carotid IMT from baseline to month 12.
Secondary Outcome Measure Information:
Title
Mean change from baseline to month 12 of carotid internal diameter (ID)
Title
wall cross sectional area (WCSA); carotid arterial mass (AM)
Title
pulse pressure (PP); cross sectional distensibility and compliance (DC and CC)
Title
pulse wave velocity (PWV); Lipid profile

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Afsnee GENT
ZIP/Postal Code
9051
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Assenede
ZIP/Postal Code
9960
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
1180
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1030
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1050
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1190
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Ertvelde
ZIP/Postal Code
9940
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Linkebeek
ZIP/Postal Code
1630
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Sint-niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Tielt
ZIP/Postal Code
8700
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Wetteren
ZIP/Postal Code
9230
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Wondelgem
ZIP/Postal Code
9032
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Achenheim
ZIP/Postal Code
67204
Country
France
Facility Name
Pfizer Investigational Site
City
Ancerville
ZIP/Postal Code
55170
Country
France
Facility Name
Pfizer Investigational Site
City
Augny
ZIP/Postal Code
57685
Country
France
Facility Name
Pfizer Investigational Site
City
Bar Le Duc
ZIP/Postal Code
55000
Country
France
Facility Name
Pfizer Investigational Site
City
Boersch
ZIP/Postal Code
67530
Country
France
Facility Name
Pfizer Investigational Site
City
Bois-Colombes
ZIP/Postal Code
92220
Country
France
Facility Name
Pfizer Investigational Site
City
Boissy Saint Leger
ZIP/Postal Code
94470
Country
France
Facility Name
Pfizer Investigational Site
City
Bouzonville
ZIP/Postal Code
57320
Country
France
Facility Name
Pfizer Investigational Site
City
Colombey-Les-Belles
ZIP/Postal Code
54170
Country
France
Facility Name
Pfizer Investigational Site
City
Dammarie Les Lys
ZIP/Postal Code
77190
Country
France
Facility Name
Pfizer Investigational Site
City
Docelles
ZIP/Postal Code
88460
Country
France
Facility Name
Pfizer Investigational Site
City
Dourdan
ZIP/Postal Code
91410
Country
France
Facility Name
Pfizer Investigational Site
City
Eckbolsheim
ZIP/Postal Code
67201
Country
France
Facility Name
Pfizer Investigational Site
City
Epinay S/orge
ZIP/Postal Code
91360
Country
France
Facility Name
Pfizer Investigational Site
City
Etampes
ZIP/Postal Code
91150
Country
France
Facility Name
Pfizer Investigational Site
City
Frouard
ZIP/Postal Code
54390
Country
France
Facility Name
Pfizer Investigational Site
City
Gambsheim
ZIP/Postal Code
67760
Country
France
Facility Name
Pfizer Investigational Site
City
Haguenau
ZIP/Postal Code
67500
Country
France
Facility Name
Pfizer Investigational Site
City
Kilstett
ZIP/Postal Code
67840
Country
France
Facility Name
Pfizer Investigational Site
City
Laxou
ZIP/Postal Code
54520
Country
France
Facility Name
Pfizer Investigational Site
City
le Grand Quevilly
ZIP/Postal Code
76120
Country
France
Facility Name
Pfizer Investigational Site
City
Le Mesnil Esnard
ZIP/Postal Code
76240
Country
France
Facility Name
Pfizer Investigational Site
City
Leuville Sur Orge
ZIP/Postal Code
91310
Country
France
Facility Name
Pfizer Investigational Site
City
Lingolsheim
ZIP/Postal Code
67380
Country
France
Facility Name
Pfizer Investigational Site
City
Longpont Sur Orge
ZIP/Postal Code
91310
Country
France
Facility Name
Pfizer Investigational Site
City
Mars LA Tour
ZIP/Postal Code
54800
Country
France
Facility Name
Pfizer Investigational Site
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Pfizer Investigational Site
City
Moutiers
ZIP/Postal Code
54660
Country
France
Facility Name
Pfizer Investigational Site
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Pfizer Investigational Site
City
Nancy
ZIP/Postal Code
5400
Country
France
Facility Name
Pfizer Investigational Site
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75008
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75017
Country
France
Facility Name
Pfizer Investigational Site
City
Pont a Mousson
ZIP/Postal Code
54700
Country
France
Facility Name
Pfizer Investigational Site
City
Pont-a-mousson
ZIP/Postal Code
54700
Country
France
Facility Name
Pfizer Investigational Site
City
Pulnoy
ZIP/Postal Code
54420
Country
France
Facility Name
Pfizer Investigational Site
City
Rouen
ZIP/Postal Code
76100
Country
France
Facility Name
Pfizer Investigational Site
City
Sainte Genevieve Des Bois
ZIP/Postal Code
91700
Country
France
Facility Name
Pfizer Investigational Site
City
Sauvigny
ZIP/Postal Code
55140
Country
France
Facility Name
Pfizer Investigational Site
City
Savigny Sur Orge
ZIP/Postal Code
91600
Country
France
Facility Name
Pfizer Investigational Site
City
Sotteville Les Rouen Cedex
ZIP/Postal Code
76308
Country
France
Facility Name
Pfizer Investigational Site
City
Souffelweyersheim
ZIP/Postal Code
67460
Country
France
Facility Name
Pfizer Investigational Site
City
St Max
ZIP/Postal Code
54130
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Pfizer Investigational Site
City
Terville
ZIP/Postal Code
57180
Country
France
Facility Name
Pfizer Investigational Site
City
Toul
ZIP/Postal Code
54200
Country
France
Facility Name
Pfizer Investigational Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Pfizer Investigational Site
City
Vandoeuvre
ZIP/Postal Code
54500
Country
France
Facility Name
Pfizer Investigational Site
City
Verdun
ZIP/Postal Code
55100
Country
France
Facility Name
Pfizer Investigational Site
City
Vincennes
ZIP/Postal Code
94300
Country
France
Facility Name
Pfizer Investigational Site
City
ED Voerendaal
ZIP/Postal Code
6367
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
EN Vaals
ZIP/Postal Code
6291
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
VE Maastricht
ZIP/Postal Code
6222
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21982290
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581051&StudyName=Carotid%20Atorvastatin%20Study%20in%20Hyperlipidemic%20Post-Menopausal%20Women
Description
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Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

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