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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00442845
First received: February 28, 2007
Last updated: April 4, 2007
Last verified: April 2007
  Purpose

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: 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 apolipoprotein-B (Apo-B) and change from baseline in glycosylated hemoglobin (HbA1c) was assessed at 12 weeks.

Estimated Enrollment: 2080
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442845

  Show 122 Study Locations
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: NCT00442845     History of Changes
Other Study ID Numbers: A2581087
Study First Received: February 28, 2007
Last Updated: April 4, 2007
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 21, 2014