Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration (CANACTFAST)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150371
First received: September 6, 2005
Last updated: July 1, 2009
Last verified: April 2007
  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
Drug: atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 1100
Study Start Date: June 2004
Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150371

  Show 84 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00150371     History of Changes
Other Study ID Numbers: A2581091
Study First Received: September 6, 2005
Last Updated: July 1, 2009
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
(D006937)

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014