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

Last updated on December 5, 2019

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Study Location
Pfizer Investigational Site
Mississauga, Ontario, Cameroon
Contact
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
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

NCT00442845
Pfizer
Completed
Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)

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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 SummaryPhysicians 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 DescriptionNot 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
  • Coronary Arteriosclerosis
  • Diabetes Mellitus, Type 2
  • Cerebrovascular Accident
  • Dyslipidemia
  • Peripheral Vascular Disease
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
 (submitted: February 28, 2007)
2080
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2004
Actual Primary Completion DateFebruary 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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