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CAP: Comparative Atorvastatin Pleiotropic Effects

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00163202
Collaborator
MDS Pharma Services (Industry), Bio-Inova Life Sciences International (Other)
330
Enrollment
74
Locations
38
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date :
Jun 1, 2002
Actual Study Completion Date :
Aug 1, 2005

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Calgary Alberta Canada T2E 7C5
2 Pfizer Investigational Site Edmonton Alberta Canada T6G 2S2
3 Pfizer Investigational Site Vancouver British Columbia Canada v6z 1y6
4 Pfizer Investigational Site Winnipeg Manitoba Canada R3E 0Z3
5 Pfizer Investigational Site Halifax Nova Scotia Canada B3H 2Y9
6 Pfizer Investigational Site London Ontario Canada N6G 2V2
7 Pfizer Investigational Site Oshawa Ontario Canada L1J 2K1
8 Pfizer Investigational Site Sarnia Ontario Canada N7T 4X3
9 Pfizer Investigational Site Toronto Ontario Canada M5C 2T2
10 Pfizer Investigational Site Weston Ontario Canada M9N 1W4
11 Pfizer Investigational Site Chicoutimi Quebec Canada G7H 5H6
12 Pfizer Investigational Site Laval Quebec Canada H7V 2T8
13 Pfizer Investigational Site Montreal Quebec Canada H1T 1C8
14 Pfizer Investigational Site Montreal Quebec Canada H1T 2M4
15 Pfizer Investigational Site Montreal Quebec Canada H2W 1R7
16 Pfizer Investigational Site Montreal Quebec Canada H4J 1C5
17 Pfizer Investigational Site Sherbrooke Quebec Canada J1H 5N4
18 Pfizer Investigational Site Ste-foy Quebec Canada G1V 4G2
19 Pfizer Investigational Site Saskatoon Saskatchewan Canada S7N 0W8
20 Pfizer Investigational Site Brno-Bohunice Czechia 63900
21 Pfizer Investigational Site Jindrichuv Hradec Czechia 377 38
22 Pfizer Investigational Site Prague 2 Czechia 120 00
23 Pfizer Investigational Site Prague 2 Czechia 128 08
24 Pfizer Investigational Site Prague 5 Czechia 150 06
25 Pfizer Investigational Site Clermont-ferrand Cedex France 63003
26 Pfizer Investigational Site Langres Cedex France 52206
27 Pfizer Investigational Site Besancon France 25030
28 Pfizer Investigational Site Brest France 29609
29 Pfizer Investigational Site Chambery France 73000
30 Pfizer Investigational Site Clamart France 92141
31 Pfizer Investigational Site Clermont-ferrand France 63003
32 Pfizer Investigational Site Creil France 60100
33 Pfizer Investigational Site Dijon France 21034
34 Pfizer Investigational Site Evecquemont France 78740
35 Pfizer Investigational Site GAP France 05000
36 Pfizer Investigational Site Henin-beaumont France 62256
37 Pfizer Investigational Site Le Kremlin Bicetre Cedex France 94275
38 Pfizer Investigational Site Lille France 59037
39 Pfizer Investigational Site Marseille Cedex 05 France 13385
40 Pfizer Investigational Site Metz Cedex 01 France 57038
41 Pfizer Investigational Site Monaco France 98000
42 Pfizer Investigational Site Montpellier France 34295
43 Pfizer Investigational Site Mulhouse France 68070
44 Pfizer Investigational Site Nancy France 54000
45 Pfizer Investigational Site Nantes Saint Herblain France 44805
46 Pfizer Investigational Site Paris Cedex 05 France 75230
47 Pfizer Investigational Site Paris Cedex 15 France 75908
48 Pfizer Investigational Site Paris Cedex 18 France 75877
49 Pfizer Investigational Site Paris France 75015
50 Pfizer Investigational Site Paris France 75018
51 Pfizer Investigational Site Pessac France 33064
52 Pfizer Investigational Site Poissy France 78303
53 Pfizer Investigational Site Pontoise France 95300
54 Pfizer Investigational Site Roubaix France 59056
55 Pfizer Investigational Site Saint Michel France 16470
56 Pfizer Investigational Site Thionville France 57100
57 Pfizer Investigational Site Toulouse France 31403
58 Pfizer Investigational Site Tourcoing France 59200
59 Pfizer Investigational Site Vandoeuvre Les Nancy France 54500
60 Pfizer Investigational Site Vandoeuvre France 54511
61 Pfizer Investigational Site Belchatow Poland 97-400
62 Pfizer Investigational Site Gdynia Poland 81-472
63 Pfizer Investigational Site Rawa Mazowiecka Poland 96-200
64 Pfizer Investigational Site Torun Poland 87-100
65 Pfizer Investigational Site Wroclaw Poland 50-420
66 Pfizer Investigational Site Zamosc Poland 22-400
67 Pfizer Investigational Site Bucharest Sector 2 Romania 70000
68 Pfizer Investigational Site Bucharest Sector 2 Romania 7000
69 Pfizer Investigational Site Bucharest Sector 5 Romania 76251
70 Pfizer Investigational Site Moscow Russian Federation 101953
71 Pfizer Investigational Site Moscow Russian Federation 121552
72 Pfizer Investigational Site Volgograd Russian Federation 400008
73 Pfizer Investigational Site Bratislava Slovakia 81369
74 Pfizer Investigational Site Bratislava Slovakia 83348

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  • MDS Pharma Services
  • Bio-Inova Life Sciences International

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00163202
Other Study ID Numbers:
  • A2581065
First Posted:
Sep 13, 2005
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Hypercholesterolemia
Atorvastatin

Study Results

No Results Posted as of Feb 18, 2021