Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)

NCT00442845

Last updated date
Study Location
Pfizer Investigational Site
Mississauga, Ontario, , Cameroon
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, Type 2 Diabetes Mellitus, Cerebrovascular Accident, Dyslipidemia, Peripheral Vascular Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.

- Triglycerides up to 600 mg/dL.

- History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events

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


- Pregnancy or lactation, use of high statin doses (>40mg) at baseline, liver or renal
problems, use of other drugs that would interfere with evaluation of efficacy or cause
safety problems, uncontrolled hypertension, diabetes or hypothyroidism, recent cardiac
event of procedure, high baseline CPK levels

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ALL GENDERS
18 Years+
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MULTIPLE SITES
Coronary Arteriosclerosis, Type 2 Diabetes Mellitus, Cerebrovascular Accident, Dyslipidemia, Peripheral Vascular DiseaseEstablish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST) NCT00442845
  1. Mississauga, Ontario
  2. Calgary, Alberta
  3. Edmonton, Alberta
  4. Medicine Hat, Alberta
  5. Red Deer, Alberta
  6. Campbell River, British Columbia
  7. Maple Ridge, British Columbia
  8. Nanaimo, British Columbia
  9. New Westminster, British Columbia
  10. Richmond, British Columbia
  11. Surrey, British Columbia
  12. Vancouver, British Columbia
  13. Vernon, British Columbia
  14. Victoria, British Columbia
  15. Brandon, Manitoba
  16. Winnipeg, Manitoba
  17. Ajax, Ontario
  18. Brampton, Ontario
  19. Burlington, Ontario
  20. Cambridge, Ontario
  21. Cornwall, Ontario
  22. Etobicoke, Ontario
  23. Mississauga, Ontario
  24. Niagara Falls, Ontario
  25. North York, Ontario
  26. Orillia, Ontario
  27. Oshawa, Ontario
  28. Rexdale, Ontario
  29. Sarnia, Ontario
  30. Scarborough, Ontario
  31. Simcoe, Ontario
  32. Thunder Bay, Ontario
  33. Toronto, Ontario
  34. Weston, Ontario
  35. Whitby, Ontario
  36. Willowdale, Ontario
  37. Chicoutimi, Quebec
  38. Cowansville, Quebec
  39. Drummondville, Quebec
  40. Joliette, Quebec
  41. Laval, Quebec
  42. Levis, Quebec
  43. Maria, Quebec
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  64. Bolzano,
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  66. Chieti,
  67. Ferrara,
  68. Firenze,
  69. Foggia,
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  72. Novara,
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ALL GENDERS
18 Years+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
Official Title  ICMJE ACTFAST: Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration. A Multicenter, Twelve-Week Treatment, Single Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving Low Density Lipoprotein Cholesterol (LDL-C) Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg
Brief Summary Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Arteriosclerosis
  • Diabetes Mellitus, Type 2
  • Cerebrovascular Accident
  • Dyslipidemia
  • Peripheral Vascular Disease
Intervention  ICMJE Drug: Atorvastatin (Lipitor)
Study Arms  ICMJE Not Provided
Publications *

*   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: February 28, 2007)
2080
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.
  • Triglycerides up to 600 mg/dL.
  • History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events

Exclusion Criteria:

  • Pregnancy or lactation, use of high statin doses (>40mg) at baseline, liver or renal problems, use of other drugs that would interfere with evaluation of efficacy or cause safety problems, uncontrolled hypertension, diabetes or hypothyroidism, recent cardiac event of procedure, high baseline CPK levels
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Cameroon,   Canada,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00442845
Other Study ID Numbers  ICMJE A2581087
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2015

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