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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00442325
Collaborator
(none)
595
33
13
18
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Atorvastatin (Lipitor)
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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.
Study Start Date :
Jan 1, 2003
Study Completion Date :
Feb 1, 2004

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Percentage of subjects achieving: []

  2. LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment. []

  3. Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment. []

  4. 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. []

  5. 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. []

  6. 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. []

  7. LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%). []

  8. 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Ioannina Greece
2 Pfizer Investigational Site Kallithea, Athens Greece
3 Pfizer Investigational Site Pireaus Greece
4 Pfizer Investigational Site Thessaloniki Greece
5 Pfizer Investigational Site Budapest Hungary
6 Pfizer Investigational Site Gyula Hungary
7 Pfizer Investigational Site Kecskemet Hungary
8 Pfizer Investigational Site Nyíregyháza Hungary
9 Pfizer Investigational Site Szekszárd Hungary
10 Pfizer Investigational Site Tullamore CO. Offlay Ireland
11 Pfizer Investigational Site Tallaght Dublin Ireland
12 Pfizer Investigational Site Gorey Wexford Ireland
13 Pfizer Investigational Site Cork Ireland
14 Pfizer Investigational Site Dublin 8 Ireland
15 Pfizer Investigational Site Dublin Ireland
16 Pfizer Investigational Site Galway Ireland
17 Pfizer Investigational Site Czestochowa Poland
18 Pfizer Investigational Site Poznan Poland
19 Pfizer Investigational Site Warszawa Poland
20 Pfizer Investigational Site Wroclaw Poland
21 Pfizer Investigational Site Zabrze Poland
22 Pfizer Investigational Site Aveiro Portugal
23 Pfizer Investigational Site Lisboa Portugal
24 Pfizer Investigational Site Porto Portugal
25 Pfizer Investigational Site Vila Franca de Xira Portugal
26 Pfizer Investigational Site Moscow Russian Federation
27 Pfizer Investigational Site Bratislava Slovakia
28 Pfizer Investigational Site Kosice Slovakia
29 Pfizer Investigational Site Bern Switzerland
30 Pfizer Investigational Site Genève Switzerland
31 Pfizer Investigational Site Mendrisio Switzerland
32 Pfizer Investigational Site Zürich Switzerland
33 Pfizer Investigational Site

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00442325
Other Study ID Numbers:
  • A2581095
First Posted:
Mar 1, 2007
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021

Study Results

No Results Posted as of Feb 18, 2021