- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00442325
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST 2)
February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ACTFAST (2): 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.
European 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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
595
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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- Pfizer Investigational Site
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Ioannina, Greece
- Pfizer Investigational Site
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Kallithea, Athens, Greece
- Pfizer Investigational Site
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Pireaus, Greece
- Pfizer Investigational Site
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Thessaloniki, Greece
- Pfizer Investigational Site
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Budapest, Hungary
- Pfizer Investigational Site
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Gyula, Hungary
- Pfizer Investigational Site
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Kecskemet, Hungary
- Pfizer Investigational Site
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Nyíregyháza, Hungary
- Pfizer Investigational Site
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Szekszárd, Hungary
- Pfizer Investigational Site
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Cork, Ireland
- Pfizer Investigational Site
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Dublin, Ireland
- Pfizer Investigational Site
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Dublin 8, Ireland
- Pfizer Investigational Site
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Galway, Ireland
- Pfizer Investigational Site
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CO. Offlay
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Tullamore, CO. Offlay, Ireland
- Pfizer Investigational Site
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Dublin
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Tallaght, Dublin, Ireland
- Pfizer Investigational Site
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Wexford
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Gorey, Wexford, Ireland
- Pfizer Investigational Site
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Czestochowa, Poland
- Pfizer Investigational Site
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Poznan, Poland
- Pfizer Investigational Site
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Warszawa, Poland
- Pfizer Investigational Site
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Wroclaw, Poland
- Pfizer Investigational Site
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Zabrze, Poland
- Pfizer Investigational Site
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Aveiro, Portugal
- Pfizer Investigational Site
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Lisboa, Portugal
- Pfizer Investigational Site
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Porto, Portugal
- Pfizer Investigational Site
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Vila Franca de Xira, Portugal
- Pfizer Investigational Site
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Moscow, Russian Federation
- Pfizer Investigational Site
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Bratislava, Slovakia
- Pfizer Investigational Site
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Kosice, Slovakia
- Pfizer Investigational Site
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Bern, Switzerland
- Pfizer Investigational Site
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Genève, Switzerland
- Pfizer Investigational Site
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Mendrisio, Switzerland
- Pfizer Investigational Site
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Zürich, Switzerland
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
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Secondary Outcome Measures
Outcome Measure |
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Percentage of subjects achieving:
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LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
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Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
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Either the LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
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Both the LDL-C <100mg/dL (<2.6 mmol/L) and TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
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LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment by LDL-C strata.
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LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
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The mean percent change in LDL-C, high density lipoprotein cholesterol (HDL-C),TC/HDL-C ratio, non HDL-C (in subjects with triglycerides [TG] ≥200 mg/dL or 2.3 mmol/L), TC and TG from baseline to 6 and 12 weeks of treatment. Change from baseline in apol
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion
February 1, 2004
Study Registration Dates
First Submitted
February 28, 2007
First Submitted That Met QC Criteria
February 28, 2007
First Posted (Estimate)
March 1, 2007
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Atherosclerosis
- Coronary Disease
- Lipid Metabolism Disorders
- Stroke
- Coronary Artery Disease
- Myocardial Ischemia
- Diabetes Mellitus, Type 2
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Dyslipidemias
- Arteriosclerosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- A2581095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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