Comparative Atorvastatin Pleiotropic Effects

NCT00163202

Last updated date
Study Location
Pfizer Investigational Site
Calgary, Alberta, T2E 7C5, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Coronary Arteriosclerosis, Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Female subjects of childbearing potential without contraception


- Subjects with secondary hyperlipidemia


- Diabetic subjects receiving insulin


- Subjects with a contra-indication to statin therapy.

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Coronary Arteriosclerosis, HypercholesterolemiaComparative Atorvastatin Pleiotropic Effects NCT00163202
  1. Calgary, Alberta
  2. Edmonton, Alberta
  3. Vancouver, British Columbia
  4. Winnipeg, Manitoba
  5. Halifax, Nova Scotia
  6. London, Ontario
  7. Oshawa, Ontario
  8. Sarnia, Ontario
  9. Toronto, Ontario
  10. Weston, Ontario
  11. Chicoutimi, Quebec
  12. Laval, Quebec
  13. Montreal, Quebec
  14. Montreal, Quebec
  15. Montreal, Quebec
  16. Montreal, Quebec
  17. Sherbrooke, Quebec
  18. Ste-foy, Quebec
  19. Saskatoon, Saskatchewan
  20. Brno-Bohunice,
  21. Jindrichuv Hradec,
  22. Prague 2,
  23. Prague 2,
  24. Prague 5,
  25. Clermont-ferrand, Cedex
  26. Langres, Cedex
  27. Besancon,
  28. Brest,
  29. Chambery,
  30. Clamart,
  31. Clermont-ferrand,
  32. Creil,
  33. Dijon,
  34. Evecquemont,
  35. GAP,
  36. Henin-beaumont,
  37. Le Kremlin Bicetre Cedex,
  38. Lille,
  39. Marseille Cedex 05,
  40. Metz Cedex 01,
  41. Monaco,
  42. Montpellier,
  43. Mulhouse,
  44. Nancy,
  45. Nantes Saint Herblain,
  46. Paris Cedex 05,
  47. Paris Cedex 15,
  48. Paris Cedex 18,
  49. Paris,
  50. Paris,
  51. Pessac,
  52. Poissy,
  53. Pontoise,
  54. Roubaix,
  55. Saint Michel,
  56. Thionville,
  57. Toulouse,
  58. Tourcoing,
  59. Vandoeuvre Les Nancy,
  60. Vandoeuvre,
  61. Belchatow,
  62. Gdynia,
  63. Rawa Mazowiecka,
  64. Torun,
  65. Wroclaw,
  66. Zamosc,
  67. Bucharest, Sector 2
  68. Bucharest, Sector 2
  69. Bucharest, Sector 5
  70. Moscow,
  71. Moscow,
  72. Volgograd,
  73. Bratislava,
  74. Bratislava,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparative Atorvastatin Pleiotropic Effects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Arteriosclerosis
  • Hypercholesterolemia
Intervention  ICMJE
  • Procedure: Blood samples
  • Drug: Atorvastatin
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
330
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czech Republic,   France,   Poland,   Romania,   Russian Federation,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163202
Other Study ID Numbers  ICMJE A2581065
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • MDS Pharma Services
  • Bio-Inova Life Sciences International
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP