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

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

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

        • Pfizer Investigational Site
      • Ioannina, Greece
        • Pfizer Investigational Site
      • Kallithea, Athens, Greece
        • Pfizer Investigational Site
      • Pireaus, Greece
        • Pfizer Investigational Site
      • Thessaloniki, Greece
        • 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
      • Cork, Ireland
        • Pfizer Investigational Site
      • Dublin, Ireland
        • Pfizer Investigational Site
      • Dublin 8, Ireland
        • Pfizer Investigational Site
      • Galway, Ireland
        • Pfizer Investigational Site
    • CO. Offlay
      • Tullamore, CO. Offlay, Ireland
        • Pfizer Investigational Site
    • Dublin
      • Tallaght, Dublin, Ireland
        • Pfizer Investigational Site
    • Wexford
      • Gorey, Wexford, Ireland
        • 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
        • Pfizer Investigational Site
      • Aveiro, Portugal
        • Pfizer Investigational Site
      • Lisboa, Portugal
        • Pfizer Investigational Site
      • Porto, Portugal
        • Pfizer Investigational Site
      • Vila Franca de Xira, Portugal
        • Pfizer Investigational Site
      • Moscow, Russian Federation
        • Pfizer Investigational Site
      • Bratislava, Slovakia
        • Pfizer Investigational Site
      • Kosice, Slovakia
        • Pfizer Investigational Site
      • Bern, Switzerland
        • Pfizer Investigational Site
      • Genève, Switzerland
        • Pfizer Investigational Site
      • Mendrisio, Switzerland
        • Pfizer Investigational Site
      • Zürich, Switzerland
        • Pfizer Investigational Site

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

Secondary Outcome Measures

Outcome Measure
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

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

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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