Comparative Atorvastatin Pleiotropic Effects (CAP)

This study has been completed.
Sponsor:
Collaborators:
MDS Pharma Services
Bio-Inova Life Sciences International
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00163202
First received: September 9, 2005
Last updated: March 14, 2008
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Coronary Arteriosclerosis
Hypercholesterolemia
Procedure: Blood samples
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Double-Blind Study Comparing The Pleiotropic Effects Of Atorvastatin 10 Mg And 80 Mg Over A 26-Week Period In Subjects With Coronary Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 330
Study Start Date: June 2002
Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163202

  Hide Study Locations
Locations
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2E 7C5
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2S2
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, v6z 1y6
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3E 0Z3
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6G 2V2
Pfizer Investigational Site
Oshawa, Ontario, Canada, L1J 2K1
Pfizer Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Pfizer Investigational Site
Toronto, Ontario, Canada, M5C 2T2
Pfizer Investigational Site
Weston, Ontario, Canada, M9N 1W4
Canada, Quebec
Pfizer Investigational Site
Chicoutimi, Quebec, Canada, G7H 5H6
Pfizer Investigational Site
Laval, Quebec, Canada, H7V 2T8
Pfizer Investigational Site
Montreal, Quebec, Canada, H2W 1R7
Pfizer Investigational Site
Montreal, Quebec, Canada, H1T 1C8
Pfizer Investigational Site
Montreal, Quebec, Canada, H1T 2M4
Pfizer Investigational Site
Montreal, Quebec, Canada, H4J 1C5
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
Pfizer Investigational Site
Ste-foy, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czech Republic
Pfizer Investigational Site
Brno-Bohunice, Czech Republic, 63900
Pfizer Investigational Site
Jindrichuv Hradec, Czech Republic, 377 38
Pfizer Investigational Site
Prague 2, Czech Republic, 128 08
Pfizer Investigational Site
Prague 2, Czech Republic, 120 00
Pfizer Investigational Site
Prague 5, Czech Republic, 150 06
France
Pfizer Investigational Site
Clermont-ferrand, Cedex, France, 63003
Pfizer Investigational Site
Langres, Cedex, France, 52206
Pfizer Investigational Site
Besancon, France, 25030
Pfizer Investigational Site
Brest, France, 29609
Pfizer Investigational Site
Chambery, France, 73000
Pfizer Investigational Site
Clamart, France, 92141
Pfizer Investigational Site
Clermont-ferrand, France, 63003
Pfizer Investigational Site
Creil, France, 60100
Pfizer Investigational Site
Dijon, France, 21034
Pfizer Investigational Site
Evecquemont, France, 78740
Pfizer Investigational Site
GAP, France, 05000
Pfizer Investigational Site
Henin-beaumont, France, 62256
Pfizer Investigational Site
Le Kremlin Bicetre Cedex, France, 94275
Pfizer Investigational Site
Lille, France, 59037
Pfizer Investigational Site
Marseille Cedex 05, France, 13385
Pfizer Investigational Site
Metz Cedex 01, France, 57038
Pfizer Investigational Site
Monaco, France, 98000
Pfizer Investigational Site
Montpellier, France, 34295
Pfizer Investigational Site
Mulhouse, France, 68070
Pfizer Investigational Site
Nancy, France, 54000
Pfizer Investigational Site
Nantes Saint Herblain, France, 44805
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Paris, France, 75018
Pfizer Investigational Site
Paris Cedex 05, France, 75230
Pfizer Investigational Site
Paris Cedex 15, France, 75908
Pfizer Investigational Site
Paris Cedex 18, France, 75877
Pfizer Investigational Site
Pessac, France, 33064
Pfizer Investigational Site
Poissy, France, 78303
Pfizer Investigational Site
Pontoise, France, 95300
Pfizer Investigational Site
Roubaix, France, 59056
Pfizer Investigational Site
Saint Michel, France, 16470
Pfizer Investigational Site
Thionville, France, 57100
Pfizer Investigational Site
Toulouse, France, 31403
Pfizer Investigational Site
Tourcoing, France, 59200
Pfizer Investigational Site
Vandoeuvre, France, 54511
Pfizer Investigational Site
Vandoeuvre Les Nancy, France, 54500
Poland
Pfizer Investigational Site
Belchatow, Poland, 97-400
Pfizer Investigational Site
Gdynia, Poland, 81-472
Pfizer Investigational Site
Rawa Mazowiecka, Poland, 96-200
Pfizer Investigational Site
Torun, Poland, 87-100
Pfizer Investigational Site
Wroclaw, Poland, 50-420
Pfizer Investigational Site
Zamosc, Poland, 22-400
Romania
Pfizer Investigational Site
Bucharest, Sector 2, Romania, 70000
Pfizer Investigational Site
Bucharest, Sector 2, Romania, 7000
Pfizer Investigational Site
Bucharest, Sector 5, Romania, 76251
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 101953
Pfizer Investigational Site
Moscow, Russian Federation, 121552
Pfizer Investigational Site
Volgograd, Russian Federation, 400008
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 81369
Pfizer Investigational Site
Bratislava, Slovakia, 83348
Sponsors and Collaborators
Pfizer
MDS Pharma Services
Bio-Inova Life Sciences International
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00163202     History of Changes
Other Study ID Numbers: A2581065
Study First Received: September 9, 2005
Last Updated: March 14, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Hypercholesterolemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014