Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration
NCT00150371
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- Age 30 to 79 years old
- Triglyceride level 6.8 mmol/L at screening
- LDL-C of 5.7 mmol/L at screening
- 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)
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Descriptive Information | ||||
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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 | 1100 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |