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Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets

Last updated on December 4, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ioannina, , Greece
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

NCT00442325
Pfizer
Completed
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets

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Descriptive Information
Brief Title  ICMJE Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
Official Title  ICMJE 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.
Brief SummaryEuropean 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)
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 *Farsang C, Athyros V, Gaw A; ACTFAST-2 investigators and Steering Committee members. A multicentre, open study to assess the effect of individualizing starting doses of atorvastatin according to baseline LDL-C levels on achieving cholesterol targets: the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST-2) study. Curr Med Res Opin. 2007 Aug;23(8):1945-56.


*   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)
595
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2004
Primary Completion DateNot Provided
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 Greece,   Hungary,   Ireland,   Poland,   Portugal,   Russian Federation,   Slovakia,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00442325
Other Study ID Numbers  ICMJE A2581095
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2007

ICMJE     Data element required by the

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

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

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1-800-718-1021

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