NCT00442845

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,080

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_4

Geographic Reach
4 countries

65 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

February 28, 2007

Last Update Submit

February 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

  • 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.

  • +4 more secondary outcomes

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (121)

Pfizer Investigational Site

Mississauga, Ontario, Cameroon

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Pfizer Investigational Site

Calgary, Alberta, Canada

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Pfizer Investigational Site

Edmonton, Alberta, Canada

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Medicine Hat, Alberta, Canada

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Red Deer, Alberta, Canada

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Campbell River, British Columbia, Canada

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Maple Ridge, British Columbia, Canada

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Nanaimo, British Columbia, Canada

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New Westminster, British Columbia, Canada

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Richmond, British Columbia, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vernon, British Columbia, Canada

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Victoria, British Columbia, Canada

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Brandon, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Ajax, Ontario, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Cambridge, Ontario, Canada

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Cornwall, Ontario, Canada

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Etobicoke, Ontario, Canada

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Mississauga, Ontario, Canada

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Niagara Falls, Ontario, Canada

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North YORK, Ontario, Canada

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Orillia, Ontario, Canada

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Oshawa, Ontario, Canada

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Rexdale, Ontario, Canada

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Sarnia, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Simcoe, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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Whitby, Ontario, Canada

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Willowdale, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Cowansville, Quebec, Canada

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Drummondville, Quebec, Canada

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Joliette, Quebec, Canada

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Laval, Quebec, Canada

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Lévis, Quebec, Canada

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Maria, Quebec, Canada

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Montreal, Quebec, Canada

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Newport, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Repentigny, Quebec, Canada

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Saint-Hyacinthe, Quebec, Canada

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Saint-Lambert, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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St-georges (beauce), Quebec, Canada

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Thetford-Mines, Quebec, Canada

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Vaudreuil, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Québec, Canada

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Tricase, (LE), Italy

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Vimercate, (MI), Italy

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Somma Lombardo, (VA), Italy

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Asti, Italy

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Bari, Italy

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Belluno, Italy

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Bologna, Italy

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Bolzano, Italy

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Catania, Italy

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Chieti, Italy

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Ferrara, Italy

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Florence, Italy

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Foggia, Italy

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Grosseto, Italy

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Napoli, Italy

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Novara, Italy

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Palermo, Italy

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Perugia, Italy

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Potenza, Italy

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Prato, Italy

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Roma, Italy

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Salerno, Italy

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San Donato Milanese, Italy

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Sassari, Italy

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Savona, Italy

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Siena, Italy

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Torino, Italy

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Venezia, Italy

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L'Hospitalet de Llobregat, Barcelona, Spain

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Girona, Catalonia, Spain

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Galdakao, Vizcaya, Spain

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Ávila, Spain

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Barcelona, Spain

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Granada, Spain

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Huelva, Spain

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Jerez de la Frontera, Spain

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Madrid, Spain

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Marbella, Spain

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Seville, Spain

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Tarragona, Spain

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Valencia, Spain

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Newtonabbey, Belfast, United Kingdom

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Aylesbury, Buckinghamshire, United Kingdom

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Ely, Cambs, United Kingdom

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Peterborough, Cambs, United Kingdom

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Newtonabbey, CO Antrim, United Kingdom

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Hastings, EAST Sussex, United Kingdom

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High Valleyfield, FIFE, United Kingdom

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Rutherglen, Glasgow, United Kingdom

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Leslie, FIFE, Glenrotheshire, United Kingdom

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Sunbury-on-Thames, Middlesex, United Kingdom

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Frome, Somerset, United Kingdom

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Barry, South Glamorgan, United Kingdom

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Doncaster, South Yorkshire, United Kingdom

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Stairfoot, Barnsley, South Yorkshire, United Kingdom

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Addlestone, Surrey, United Kingdom

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East Horsley, Surrey, United Kingdom

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Atherstone, Warks, United Kingdom

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Balsall Common, WEST Midlands, United Kingdom

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Pound Hill, Crawley, WEST Sussex, United Kingdom

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Trowbridge, Wiltshire, United Kingdom

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Chippenham, Wilts, United Kingdom

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Sheffield, Yorkshire, United Kingdom

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Bath, United Kingdom

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Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus, Type 2StrokeDyslipidemiasPeripheral Vascular Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 2, 2007

Study Start

January 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations