NCT00163202

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2002

Typical duration for phase_4

Geographic Reach
7 countries

74 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

First QC Date

September 9, 2005

Last Update Submit

February 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).

Secondary Outcomes (1)

  • 1/ the percentage change at visit 3 (5-week treatment), visit 4 (13-week-treatment) and visit 5 (26-week treatment) from baseline value in triglycerides, total cholesterol; HDL-cholesterol, LDL-cholesterol, apolipoprotein B 2/ the percentage change at

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (74)

Pfizer Investigational Site

Calgary, Alberta, T2E 7C5, Canada

Location

Pfizer Investigational Site

Edmonton, Alberta, T6G 2S2, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, v6z 1y6, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3E 0Z3, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Pfizer Investigational Site

London, Ontario, N6G 2V2, Canada

Location

Pfizer Investigational Site

Oshawa, Ontario, L1J 2K1, Canada

Location

Pfizer Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5C 2T2, Canada

Location

Pfizer Investigational Site

Weston, Ontario, M9N 1W4, Canada

Location

Pfizer Investigational Site

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Pfizer Investigational Site

Laval, Quebec, H7V 2T8, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1T 1C8, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1T 2M4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2W 1R7, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H4J 1C5, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Pfizer Investigational Site

Ste-foy, Quebec, G1V 4G2, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Pfizer Investigational Site

Brno-Bohunice, 63900, Czechia

Location

Pfizer Investigational Site

Jindřichův Hradec, 377 38, Czechia

Location

Pfizer Investigational Site

Prague, 120 00, Czechia

Location

Pfizer Investigational Site

Prague, 128 08, Czechia

Location

Pfizer Investigational Site

Prague, 150 06, Czechia

Location

Pfizer Investigational Site

Clermont-Ferrand, Cedex, 63003, France

Location

Pfizer Investigational Site

Langres, Cedex, 52206, France

Location

Pfizer Investigational Site

Besançon, 25030, France

Location

Pfizer Investigational Site

Brest, 29609, France

Location

Pfizer Investigational Site

Chambéry, 73000, France

Location

Pfizer Investigational Site

Clamart, 92141, France

Location

Pfizer Investigational Site

Clermont-Ferrand, 63003, France

Location

Pfizer Investigational Site

Creil, 60100, France

Location

Pfizer Investigational Site

Dijon, 21034, France

Location

Pfizer Investigational Site

Évecquemont, 78740, France

Location

Pfizer Investigational Site

Gap, 05000, France

Location

Pfizer Investigational Site

Hénin-Beaumont, 62256, France

Location

Pfizer Investigational Site

Le Kremlin-Bicêtre, 94275, France

Location

Pfizer Investigational Site

Lille, 59037, France

Location

Pfizer Investigational Site

Marseille, 13385, France

Location

Pfizer Investigational Site

Metz, 57038, France

Location

Pfizer Investigational Site

Monaco, 98000, France

Location

Pfizer Investigational Site

Montpellier, 34295, France

Location

Pfizer Investigational Site

Mulhouse, 68070, France

Location

Pfizer Investigational Site

Nancy, 54000, France

Location

Pfizer Investigational Site

Nantes Saint Herblain, 44805, France

Location

Pfizer Investigational Site

Paris, 75015, France

Location

Pfizer Investigational Site

Paris, 75018, France

Location

Pfizer Investigational Site

Paris, 75230, France

Location

Pfizer Investigational Site

Paris, 75877, France

Location

Pfizer Investigational Site

Paris, 75908, France

Location

Pfizer Investigational Site

Pessac, 33064, France

Location

Pfizer Investigational Site

Poissy, 78303, France

Location

Pfizer Investigational Site

Pontoise, 95300, France

Location

Pfizer Investigational Site

Roubaix, 59056, France

Location

Pfizer Investigational Site

Saint-Michel, 16470, France

Location

Pfizer Investigational Site

Thionville, 57100, France

Location

Pfizer Investigational Site

Toulouse, 31403, France

Location

Pfizer Investigational Site

Tourcoing, 59200, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54500, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Pfizer Investigational Site

Bełchatów, 97-400, Poland

Location

Pfizer Investigational Site

Gdynia, 81-472, Poland

Location

Pfizer Investigational Site

Rawa Mazowiecka, 96-200, Poland

Location

Pfizer Investigational Site

Torun, 87-100, Poland

Location

Pfizer Investigational Site

Wroclaw, 50-420, Poland

Location

Pfizer Investigational Site

Zamość, 22-400, Poland

Location

Pfizer Investigational Site

Bucharest, Sector 2, 70000, Romania

Location

Pfizer Investigational Site

Bucharest, Sector 2, 7000, Romania

Location

Pfizer Investigational Site

Bucharest, Sector 5, 76251, Romania

Location

Pfizer Investigational Site

Moscow, 101953, Russia

Location

Pfizer Investigational Site

Moscow, 121552, Russia

Location

Pfizer Investigational Site

Volgograd, 400008, Russia

Location

Pfizer Investigational Site

Bratislava, 81369, Slovakia

Location

Pfizer Investigational Site

Bratislava, 83348, Slovakia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery DiseaseHypercholesterolemia

Interventions

Blood Specimen CollectionAtorvastatin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

June 1, 2002

Study Completion

August 1, 2005

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations