Comparative Atorvastatin Pleiotropic Effects

NCT ID: NCT00163202

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

PHASE4

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2005-08-31

Brief Summary

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The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.

Detailed Description

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Conditions

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Coronary Arteriosclerosis Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Blood samples

Intervention Type PROCEDURE

Atorvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects of age of majority to \< 80 years
* Subjects with LDL-C \> 0.5 g/L (1.29 mmol/L) and \< 1.5 g/L (3.87 mmol/L), TG \< 4.00 g/L (4.56 mmol/L) and hs-CRP \>1.5 mg/L and \< 15 mg/L
* Subjects with a documented coronary artery disease.

Exclusion Criteria

* Female subjects of childbearing potential without contraception
* Subjects with secondary hyperlipidemia
* Diabetic subjects receiving insulin
* Subjects with a contra-indication to statin therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MDS Pharma Services

INDUSTRY

Sponsor Role collaborator

Bio-Inova Life Sciences International

OTHER

Sponsor Role collaborator

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

Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Oshawa, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Ste-foy, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Brno-Bohunice, , Czechia

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Jindřichův Hradec, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Clermont-Ferrand, Cedex, France

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Langres, Cedex, France

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Besançon, , France

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Brest, , France

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Chambéry, , France

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Clamart, , France

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Clermont-Ferrand, , France

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Creil, , France

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Dijon, , France

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Évecquemont, , France

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Gap, , France

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Hénin-Beaumont, , France

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Le Kremlin-Bicêtre, , France

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Lille, , France

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Marseille, , France

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Metz, , France

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Monaco, , France

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Montpellier, , France

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Mulhouse, , France

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Nancy, , France

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Nantes Saint Herblain, , 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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Pessac, , France

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Poissy, , France

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Pontoise, , France

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Roubaix, , France

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Saint-Michel, , France

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Thionville, , France

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Toulouse, , France

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Tourcoing, , France

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Vandœuvre-lès-Nancy, , France

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Vandœuvre-lès-Nancy, , France

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Bełchatów, , Poland

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Gdynia, , Poland

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Rawa Mazowiecka, , Poland

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Torun, , Poland

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Wroclaw, , Poland

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Zamość, , Poland

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Bucharest, Sector 2, Romania

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Bucharest, Sector 2, Romania

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Bucharest, Sector 5, Romania

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Moscow, , Russia

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Moscow, , Russia

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Volgograd, , Russia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Countries

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Canada Czechia France Poland Romania Russia Slovakia

References

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Bonnet J, McPherson R, Tedgui A, Simoneau D, Nozza A, Martineau P, Davignon J; CAP Investigators. Comparative effects of 10-mg versus 80-mg Atorvastatin on high-sensitivity C-reactive protein in patients with stable coronary artery disease: results of the CAP (Comparative Atorvastatin Pleiotropic effects) study. Clin Ther. 2008 Dec;30(12):2298-313. doi: 10.1016/j.clinthera.2008.12.023.

Reference Type DERIVED
PMID: 19167589 (View on PubMed)

Other Identifiers

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A2581065

Identifier Type: -

Identifier Source: org_study_id

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