Clinical trial NCT00163202: Comparative Atorvastatin Pleiotropic Effects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Arteriosclerosis
Hypercholesterolemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: MDS Pharma Services
name: Bio-Inova Life Sciences International
First posted: 2005-09-13
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: 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
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Weston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Brno-Bohunice
country: Czechia
facility: Pfizer Investigational Site
city: Jindrichuv Hradec
country: Czechia
facility: Pfizer Investigational Site
city: Prague 2
country: Czechia
facility: Pfizer Investigational Site
city: Prague 2
country: Czechia
facility: Pfizer Investigational Site
city: Prague 5
country: Czechia
facility: Pfizer Investigational Site
city: Clermont-ferrand
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Langres
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Besancon
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Chambery
country: France
facility: Pfizer Investigational Site
city: Clamart
country: France
facility: Pfizer Investigational Site
city: Clermont-ferrand
country: France
facility: Pfizer Investigational Site
city: Creil
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Evecquemont
country: France
facility: Pfizer Investigational Site
city: GAP
country: France
facility: Pfizer Investigational Site
city: Henin-beaumont
country: France
facility: Pfizer Investigational Site
city: Le Kremlin Bicetre Cedex
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 05
country: France
facility: Pfizer Investigational Site
city: Metz Cedex 01
country: France
facility: Pfizer Investigational Site
city: Monaco
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Mulhouse
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Nantes Saint Herblain
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 05
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 15
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 18
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Pessac
country: France
facility: Pfizer Investigational Site
city: Poissy
country: France
facility: Pfizer Investigational Site
city: Pontoise
country: France
facility: Pfizer Investigational Site
city: Roubaix
country: France
facility: Pfizer Investigational Site
city: Saint Michel
country: France
facility: Pfizer Investigational Site
city: Thionville
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Tourcoing
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre
country: France
facility: Pfizer Investigational Site
city: Belchatow
country: Poland
facility: Pfizer Investigational Site
city: Gdynia
country: Poland
facility: Pfizer Investigational Site
city: Rawa Mazowiecka
country: Poland
facility: Pfizer Investigational Site
city: Torun
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Zamosc
country: Poland
facility: Pfizer Investigational Site
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
state: Sector 2
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
state: Sector 2
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
state: Sector 5
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Volgograd
country: Russian Federation
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.