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

Primary Purpose

Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Atorvastatin (Lipitor)
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

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.

Full Information

First Posted
February 28, 2007
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00442845
Brief Title
Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
Acronym
ACTFAST
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia, Peripheral Vascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2080 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin (Lipitor)
Primary Outcome Measure Information:
Title
Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving:
Title
LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
Title
Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
Title
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.
Title
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.
Title
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.
Title
LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
Title
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.
Title
Change from baseline in apolipoprotein-B (Apo-B) and change from baseline in glycosylated hemoglobin (HbA1c) was assessed at 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Mississauga
State/Province
Ontario
Country
Cameroon
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Pfizer Investigational Site
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Calgary
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Alberta
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Canada
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Pfizer Investigational Site
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Edmonton
State/Province
Alberta
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Canada
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Pfizer Investigational Site
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Medicine Hat
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Alberta
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Canada
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Pfizer Investigational Site
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Red Deer
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Alberta
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Canada
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Pfizer Investigational Site
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Campbell River
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British Columbia
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Canada
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Pfizer Investigational Site
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Maple Ridge
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British Columbia
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Canada
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Pfizer Investigational Site
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Nanaimo
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British Columbia
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Canada
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New Westminster
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British Columbia
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Canada
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Pfizer Investigational Site
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Richmond
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British Columbia
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Canada
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Surrey
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British Columbia
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Canada
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Pfizer Investigational Site
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Vancouver
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British Columbia
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Canada
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Vernon
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British Columbia
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Canada
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Pfizer Investigational Site
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Victoria
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British Columbia
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Canada
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Brandon
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Manitoba
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Canada
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Winnipeg
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Manitoba
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Canada
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Pfizer Investigational Site
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Ajax
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Ontario
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Canada
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Pfizer Investigational Site
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Brampton
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Ontario
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Canada
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Pfizer Investigational Site
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Burlington
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Ontario
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Canada
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Pfizer Investigational Site
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Cambridge
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Cornwall
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Canada
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Etobicoke
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Ontario
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Canada
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Mississauga
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Ontario
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Canada
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Pfizer Investigational Site
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Niagara Falls
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Ontario
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Canada
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Pfizer Investigational Site
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North York
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Ontario
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Orillia
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Oshawa
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Rexdale
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Sarnia
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Scarborough
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Pfizer Investigational Site
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Simcoe
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Pfizer Investigational Site
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Thunder Bay
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Pfizer Investigational Site
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Toronto
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Pfizer Investigational Site
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Weston
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Whitby
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Willowdale
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Ontario
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Chicoutimi
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Quebec
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Canada
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Pfizer Investigational Site
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Cowansville
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Quebec
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Canada
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Pfizer Investigational Site
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Drummondville
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Quebec
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Canada
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Pfizer Investigational Site
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Joliette
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Canada
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Pfizer Investigational Site
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Laval
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Levis
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Maria
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Montreal
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Newport
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Pointe Claire
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Repentigny
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Canada
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Pfizer Investigational Site
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Saint Hyacinthe
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Quebec
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Canada
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Pfizer Investigational Site
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Sainte Foy
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Quebec
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Canada
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Pfizer Investigational Site
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Sherbrooke
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Quebec
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Canada
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Pfizer Investigational Site
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St-georges (beauce)
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Quebec
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Canada
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Pfizer Investigational Site
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St. Lambert
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Quebec
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Thetford Mines
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Quebec
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Pfizer Investigational Site
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Vaudreuil
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Quebec
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Canada
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Saskatoon
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Saskatchewan
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Canada
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Pfizer Investigational Site
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Quebec
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Canada
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Pfizer Investigational Site
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Tricase
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(le)
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Italy
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Pfizer Investigational Site
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Vimercate
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Italy
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Somma Lombardo
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Italy
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Asti
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Bari
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Belluno
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Italy
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Bologna
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Italy
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Bolzano
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Italy
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Catania
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Italy
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Chieti
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Firenze
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Foggia
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Italy
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Grosseto
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Novara
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Palermo
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Perugia
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Potenza
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Pfizer Investigational Site
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Prato
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Roma
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Italy
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Salerno
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Italy
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Pfizer Investigational Site
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San Donato Milanese
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Italy
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Pfizer Investigational Site
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Sassari
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Italy
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Pfizer Investigational Site
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Savona
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Italy
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Pfizer Investigational Site
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Siena
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Italy
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Pfizer Investigational Site
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Torino
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Italy
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Pfizer Investigational Site
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Venezia
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Italy
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Pfizer Investigational Site
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Hospitalet de Llobregat
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Barcelona
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Spain
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Pfizer Investigational Site
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Girona
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Cataluna
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Spain
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Pfizer Investigational Site
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Galdakao
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Vizcaya
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Spain
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Pfizer Investigational Site
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Avila
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Spain
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Pfizer Investigational Site
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Barcelona
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Spain
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Pfizer Investigational Site
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Granada
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Spain
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Pfizer Investigational Site
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Huelva
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Spain
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Pfizer Investigational Site
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Jerez de La Frontera
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Spain
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Pfizer Investigational Site
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Madrid
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Spain
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Pfizer Investigational Site
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Marbella
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Spain
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Pfizer Investigational Site
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Sevilla
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Spain
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Pfizer Investigational Site
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Tarragona
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Spain
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Pfizer Investigational Site
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Valencia
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Spain
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Pfizer Investigational Site
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Newtonabbey
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Belfast
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United Kingdom
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Pfizer Investigational Site
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Aylesbury
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Buckinghamshire
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United Kingdom
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Pfizer Investigational Site
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ELY
State/Province
Cambs
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United Kingdom
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Pfizer Investigational Site
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Peterborough
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Cambs
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United Kingdom
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Pfizer Investigational Site
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Newtonabbey
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CO Antrim
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United Kingdom
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Pfizer Investigational Site
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Hastings
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EAST Sussex
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United Kingdom
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Pfizer Investigational Site
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High Valleyfield
State/Province
Fife
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United Kingdom
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Pfizer Investigational Site
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Rutherglen
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Glasgow
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United Kingdom
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Pfizer Investigational Site
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Leslie, FIFE
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Glenrotheshire
Country
United Kingdom
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Pfizer Investigational Site
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Sunbury on Thames
State/Province
Middlesex
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United Kingdom
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Pfizer Investigational Site
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Frome
State/Province
Somerset
Country
United Kingdom
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Pfizer Investigational Site
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Barry
State/Province
South Glamorgan
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United Kingdom
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Pfizer Investigational Site
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Doncaster
State/Province
South Yorkshire
Country
United Kingdom
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Pfizer Investigational Site
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Stairfoot, Barnsley
State/Province
South Yorkshire
Country
United Kingdom
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Pfizer Investigational Site
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Addlestone
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Surrey
Country
United Kingdom
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Pfizer Investigational Site
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East Horsley
State/Province
Surrey
Country
United Kingdom
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Pfizer Investigational Site
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Atherstone
State/Province
Warks
Country
United Kingdom
Facility Name
Pfizer Investigational Site
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Balsall Common
State/Province
WEST Midlands
Country
United Kingdom
Facility Name
Pfizer Investigational Site
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Pound Hill, Crawley
State/Province
WEST Sussex
Country
United Kingdom
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Pfizer Investigational Site
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Trowbridge
State/Province
Wiltshire
Country
United Kingdom
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Pfizer Investigational Site
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Chippenham
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Wilts
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United Kingdom
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Pfizer Investigational Site
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Sheffield
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Yorkshire
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United Kingdom
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Pfizer Investigational Site
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Bath
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United Kingdom
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Citations:
PubMed Identifier
21610204
Citation
Gupta M, Martineau P, Tran T, Despres JP, Gaw A, de Teresa E, Farsang C, Gensini GF, Leiter LA, Blanco-Colio LM, Egido J, Langer A; ACTFAST investigators. Low-density lipoprotein cholesterol and high-sensitivity C-reactive protein lowering with atorvastatin in patients of South Asian compared with European origin: insights from the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST) study. J Clin Pharmacol. 2012 Jun;52(6):850-8. doi: 10.1177/0091270011407196. Epub 2011 May 24.
Results Reference
derived
PubMed Identifier
19217176
Citation
Gensini GF, Gori AM, Dilaghi B, Rostagno C, Gaw A, Blanco-Colio LM, de Teresa E, Egido J, Farsang C, Leiter LA, Martineau P, Nozza A, Langer A; Achieve Cholesterol Targets Fast withAtorvastatin Stratified Titration Investigators. Effect of atorvastatin on circulating hsCRP concentrations: a sub-study of the achieve cholesterol targets fast with atorvastatin stratified titration (ACTFAST) study. Int J Cardiol. 2010 Jul 23;142(3):257-64. doi: 10.1016/j.ijcard.2008.12.213. Epub 2009 Feb 12.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581087&StudyName=Establish+The+Benefits+Of+Using+Various+Starting+Doses+Of+Atorvastatin+On+Achievement+Of+Cholesterol+Targets+%28ACTFAST%29
Description
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Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)

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