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Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

NCT ID: NCT00163163

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Echographic measurements

Intervention Type PROCEDURE

Blood samples

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Afsnee GENT, , Belgium

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Assenede, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Ertvelde, , Belgium

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Ghent, , Belgium

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Linkebeek, , Belgium

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Sint-Niklaas, , Belgium

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Tielt, , Belgium

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Wetteren, , Belgium

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Wondelgem, , Belgium

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Achenheim, , France

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Ancerville, , France

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Augny, , France

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Bar-le-Duc, , France

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Bois-Colombes, , France

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Boissy-Saint-Léger, , France

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Bouzonville, , France

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Bœrsch, , France

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Colombey-les-Belles, , France

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Dammarie-les-Lys, , France

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Docelles, , France

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Dourdan, , France

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Eckbolsheim, , France

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Epinay S/orge, , France

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Étampes, , France

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Frouard, , France

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Gambsheim, , France

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Haguenau, , France

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Kilstett, , France

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Laxou, , France

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Le Grand-Quevilly, , France

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Le Mesnil-Esnard, , France

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Leuville-sur-Orge, , France

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Lingolsheim, , France

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Longpont-sur-Orge, , France

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Mars-la-Tour, , France

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Metz, , France

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Moûtiers, , France

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Nancy, , France

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Nancy, , France

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Nancy, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pont-à-Mousson, , France

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Pulnoy, , France

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Rouen, , France

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Saint-Max, , France

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Sainte-Geneviève-des-Bois, , France

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Sauvigny, , France

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Savigny-sur-Orge, , France

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Sotteville-lès-Rouen, , France

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Souffelweyersheim, , France

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Strasbourg, , France

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Strasbourg, , France

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Terville, , France

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Toul, , France

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Vandœuvre-lès-Nancy, , France

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Verdun, , France

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Vincennes, , France

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ED Voerendaal, , Netherlands

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EN Vaals, , Netherlands

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VE Maastricht, , Netherlands

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Countries

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Belgium France Netherlands

References

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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.

Reference Type DERIVED
PMID: 21982290 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581051&StudyName=Carotid%20Atorvastatin%20Study%20in%20Hyperlipidemic%20Post-Menopausal%20Women

To obtain contact information for a study center near you, click here.

Other Identifiers

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A2581051

Identifier Type: -

Identifier Source: org_study_id

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