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Canactfast: Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration - Article


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Cholesterol

 



Clinical Trial: Canactfast: Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration

This study has been completed.

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00150371

Purpose

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
Condition Intervention Phase
Hypercholesterolemia (D006937)
 Drug: atorvastatin
Phase IV

MedlinePlus related topics:  Cholesterol

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title: 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.

Further Study Details: 
Primary Outcomes: Proportion (%) of subjects achieving their LDL-C target after 12 weeks of treatment according to their 10-year CHD risk category (based on the new canadian guidelines on the management and treatment of dyslipidemia).
Secondary Outcomes: The global proportion (%) of patients reaching targets when risk categories are combined The proportion (%) of subjects achieving BOTH their LDL-C and TC/HDL-C ratio targets after 6 and 12 weeks of treatment, globally and according to their 10-year
Expected Total Enrollment:  1100

Study start: June 2004

Eligibility

Ages Eligible for Study:  30 Years   -   79 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Age 30 to 79 years old
  • Triglyceride level ï‚£ 6.8 mmol/L at screening
  • LDL-C of ï‚£ 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)

Location Information

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A2581091
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150371
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13

Resources



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