Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
NCT00442845
Last updated date
ABOUT THIS STUDY
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)
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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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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
- Mississauga, Ontario
- Calgary, Alberta
- Edmonton, Alberta
- Medicine Hat, Alberta
- Red Deer, Alberta
- Campbell River, British Columbia
- Maple Ridge, British Columbia
- Nanaimo, British Columbia
- New Westminster, British Columbia
- Richmond, British Columbia
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- Vancouver, British Columbia
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- Brandon, Manitoba
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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 |
| |||
| 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||