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Comparative Atorvastatin Pleiotropic Effects (CAP)

Primary Purpose

Coronary Arteriosclerosis, Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Blood samples
Atorvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators
MDS Pharma Services, Bio-Inova Life Sciences International
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1. Study Identification

Unique Protocol Identification Number
NCT00163202
Brief Title
Comparative Atorvastatin Pleiotropic Effects
Acronym
CAP
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators
MDS Pharma Services, Bio-Inova Life Sciences International

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Blood samples
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E 7C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2S2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
v6z 1y6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0Z3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2V2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1W4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7V 2T8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Brno-Bohunice
ZIP/Postal Code
63900
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 38
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Prague 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Prague 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Prague 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Clermont-ferrand
State/Province
Cedex
ZIP/Postal Code
63003
Country
France
Facility Name
Pfizer Investigational Site
City
Langres
State/Province
Cedex
ZIP/Postal Code
52206
Country
France
Facility Name
Pfizer Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Pfizer Investigational Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Pfizer Investigational Site
City
Chambery
ZIP/Postal Code
73000
Country
France
Facility Name
Pfizer Investigational Site
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Pfizer Investigational Site
City
Creil
ZIP/Postal Code
60100
Country
France
Facility Name
Pfizer Investigational Site
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Pfizer Investigational Site
City
Evecquemont
ZIP/Postal Code
78740
Country
France
Facility Name
Pfizer Investigational Site
City
GAP
ZIP/Postal Code
05000
Country
France
Facility Name
Pfizer Investigational Site
City
Henin-beaumont
ZIP/Postal Code
62256
Country
France
Facility Name
Pfizer Investigational Site
City
Le Kremlin Bicetre Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Pfizer Investigational Site
City
Metz Cedex 01
ZIP/Postal Code
57038
Country
France
Facility Name
Pfizer Investigational Site
City
Monaco
ZIP/Postal Code
98000
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Pfizer Investigational Site
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
Pfizer Investigational Site
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Pfizer Investigational Site
City
Nantes Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 05
ZIP/Postal Code
75230
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Pfizer Investigational Site
City
Pessac
ZIP/Postal Code
33064
Country
France
Facility Name
Pfizer Investigational Site
City
Poissy
ZIP/Postal Code
78303
Country
France
Facility Name
Pfizer Investigational Site
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Pfizer Investigational Site
City
Roubaix
ZIP/Postal Code
59056
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Michel
ZIP/Postal Code
16470
Country
France
Facility Name
Pfizer Investigational Site
City
Thionville
ZIP/Postal Code
57100
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Pfizer Investigational Site
City
Tourcoing
ZIP/Postal Code
59200
Country
France
Facility Name
Pfizer Investigational Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Pfizer Investigational Site
City
Vandoeuvre
ZIP/Postal Code
54511
Country
France
Facility Name
Pfizer Investigational Site
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
Facility Name
Pfizer Investigational Site
City
Gdynia
ZIP/Postal Code
81-472
Country
Poland
Facility Name
Pfizer Investigational Site
City
Rawa Mazowiecka
ZIP/Postal Code
96-200
Country
Poland
Facility Name
Pfizer Investigational Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-420
Country
Poland
Facility Name
Pfizer Investigational Site
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bucharest
State/Province
Sector 2
ZIP/Postal Code
70000
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucharest
State/Province
Sector 2
ZIP/Postal Code
7000
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucharest
State/Province
Sector 5
ZIP/Postal Code
76251
Country
Romania
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
101953
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Volgograd
ZIP/Postal Code
400008
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
83348
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
19167589
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.
Results Reference
derived

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Comparative Atorvastatin Pleiotropic Effects

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