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Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration

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NCT00150371

Last updated on February 15, 2020
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Study Location
Pfizer Investigational Site
Calgary, Alberta, T2E 7C5 Canada
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-79 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age 30 to 79 years old

- Triglyceride level 6.8 mmol/L at screening

- LDL-C of 5.7 mmol/L at screening

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

- Pregnant or lactating women, or women of childbearing potential not using an
acceptable method of contraception. The latter are defined as: abstinence, surgical
sterilization, oral contraceptives for at least 3 cycles, intrauterine device,
implant, depot injection, or barrier method in conjunction with contraceptive foam or
jelly.

- Subjects whose blood cholesterol levels are controlled (LDL-C targets) with statins
other than atorvastatin

- Subjects receiving statin doses higher than the following: 10-40mg for simvastatin ,
20-40mg for fluvastatin, pravastatin and lovastatin and 10-20 mg for rosuvastatin.
Subjects already treated with atorvastatin at the time of screening are not eligible
unless atorvastatin has been discontinued at least 2 months prior to screening

- Subjects receiving 2 or more lipid lowering agents are excluded (statins + resins or
fibrates or niacin or fish oils)

NCT00150371
Pfizer
Completed
Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration

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Descriptive Information
Brief Title  ICMJE Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration
Official Title  ICMJE A Multicenter, 12 Week Treatment Single Step Titration Open-Label Study Assessing The % Of Patients Achieving Ldl-C Target With Atorvastatin Starting Doses Of 10mg, 20mg, 40mg and 80mg.
Brief Summary The objective of this study is to assess the effectiveness of an atorvastatin treatment regimen involving starting doses between 10 and 80 mg, followed by a single-step titration (except for subjects started at 80mg), if required
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE Drug: atorvastatin
Study Arms  ICMJE Not Provided
Publications * Ur E, Langer A, Rabkin SW, Calciu CD, Leiter LA; CanACTFAST Study Investigators. Achieving cholesterol targets by individualizing starting doses of statin according to baseline low-density lipoprotein cholesterol and coronary artery disease risk category: the CANadians Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (CanACTFAST) study. Can J Cardiol. 2010 Feb;26(2):80-6.


*   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 6, 2005) 		1100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 30 to 79 years old
  • Triglyceride level 6.8 mmol/L at screening
  • LDL-C of 5.7 mmol/L at screening

Exclusion Criteria:

  • Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception. The latter are defined as: abstinence, surgical sterilization, oral contraceptives for at least 3 cycles, intrauterine device, implant, depot injection, or barrier method in conjunction with contraceptive foam or jelly.
  • Subjects whose blood cholesterol levels are controlled (LDL-C targets) with statins other than atorvastatin
  • Subjects receiving statin doses higher than the following: 10-40mg for simvastatin , 20-40mg for fluvastatin, pravastatin and lovastatin and 10-20 mg for rosuvastatin. Subjects already treated with atorvastatin at the time of screening are not eligible unless atorvastatin has been discontinued at least 2 months prior to screening
  • Subjects receiving 2 or more lipid lowering agents are excluded (statins + resins or fibrates or niacin or fish oils)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 79 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00150371
Other Study ID Numbers  ICMJE A2581091
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 Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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