Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST 2)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00442325
First received: February 28, 2007
Last updated: October 24, 2007
Last verified: April 2007
  Purpose

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)


Condition Intervention Phase
Coronary Arteriosclerosis
Diabetes Mellitus, Type 2
Cerebrovascular Accident
Dyslipidemia
Peripheral Vascular Disease
Drug: Atorvastatin (Lipitor)
Phase 4

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: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.

Secondary Outcome Measures:
  • Percentage of subjects achieving:
  • LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
  • Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
  • 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.
  • 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.
  • 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.
  • LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
  • 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

Estimated Enrollment: 595
Study Start Date: January 2003
Estimated Study Completion Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442325

  Hide Study Locations
Locations
Greece
Pfizer Investigational Site
Ioannina, Greece
Pfizer Investigational Site
Kallithea, Athens, Greece
Pfizer Investigational Site
Pireaus, Greece
Pfizer Investigational Site
Thessaloniki, Greece
Hungary
Pfizer Investigational Site
Budapest, Hungary
Pfizer Investigational Site
Gyula, Hungary
Pfizer Investigational Site
Kecskemet, Hungary
Pfizer Investigational Site
Nyíregyháza, Hungary
Pfizer Investigational Site
Szekszárd, Hungary
Pfizer Investigational Site
Unknown, Hungary
Ireland
Pfizer Investigational Site
Tullamore, Co. Offlay, Ireland
Pfizer Investigational Site
Tallaght, Dublin, Ireland
Pfizer Investigational Site
Gorey, Wexford, Ireland
Pfizer Investigational Site
Cork, Ireland
Pfizer Investigational Site
Dublin, Ireland
Pfizer Investigational Site
Dublin 8, Ireland
Pfizer Investigational Site
Galway, Ireland
Pfizer Investigational Site
Unknown, Ireland
Poland
Pfizer Investigational Site
Czestochowa, Poland
Pfizer Investigational Site
Poznan, Poland
Pfizer Investigational Site
Warszawa, Poland
Pfizer Investigational Site
Wroclaw, Poland
Pfizer Investigational Site
Zabrze, Poland
Portugal
Pfizer Investigational Site
Aveiro, Portugal
Pfizer Investigational Site
Lisboa, Portugal
Pfizer Investigational Site
Porto, Portugal
Pfizer Investigational Site
Unknown, Portugal
Pfizer Investigational Site
Vila Franca de Xira, Portugal
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia
Pfizer Investigational Site
Kosice, Slovakia
Switzerland
Pfizer Investigational Site
Bern, Switzerland
Pfizer Investigational Site
Genève, Switzerland
Pfizer Investigational Site
Mendrisio, Switzerland
Pfizer Investigational Site
Zürich, Switzerland
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00442325     History of Changes
Other Study ID Numbers: A2581095
Study First Received: February 28, 2007
Last Updated: October 24, 2007
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cerebral Infarction
Stroke
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Dyslipidemias
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atherosclerosis
Lipid Metabolism Disorders
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents

ClinicalTrials.gov processed this record on April 15, 2014