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

Condition(s) targeted: Coronary Arteriosclerosis; Diabetes Mellitus, Type 2; Cerebrovascular Accident; Dyslipidemia; Peripheral Vascular Disease

Intervention: Atorvastatin (Lipitor) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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)

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 design: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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.

Minimum age: 18 Years. Gender(s): Both.

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

Pfizer Investigational Site, TRICASE, (LE), Italy

Pfizer Investigational Site, VIMERCATE, (MI), Italy

Pfizer Investigational Site, SOMMA LOMBARDO, (VA), Italy

Pfizer Investigational Site, Red Deer, Alberta, Canada

Pfizer Investigational Site, EDMONTON, Alberta, Canada

Pfizer Investigational Site, Calgary, Alberta, Canada

Pfizer Investigational Site, MEDICINE HAT, Alberta, Canada

Pfizer Investigational Site, HOSPITALET DE LLOBREGAT, BARCELONA, Spain

Pfizer Investigational Site, NEWTONABBEY, BELFAST, United Kingdom

Pfizer Investigational Site, VANCOUVER, British Columbia, Canada

Pfizer Investigational Site, MAPLE RIDGE, British Columbia, Canada

Pfizer Investigational Site, CAMPBELL RIVER, British Columbia, Canada

Pfizer Investigational Site, VICTORIA, British Columbia, Canada

Pfizer Investigational Site, RICHMOND, British Columbia, Canada

Pfizer Investigational Site, NANAIMO, British Columbia, Canada

Pfizer Investigational Site, SURREY, British Columbia, Canada

Pfizer Investigational Site, NEW WESTMINSTER, British Columbia, Canada

Pfizer Investigational Site, VERNON, British Columbia, Canada

Pfizer Investigational Site, AYLESBURY, Buckinghamshire, United Kingdom

Pfizer Investigational Site, ELY, CAMBS, United Kingdom

Pfizer Investigational Site, PETERBOROUGH, CAMBS, United Kingdom

Pfizer Investigational Site, GIRONA, CATALUNA, Spain

Pfizer Investigational Site, NEWTONABBEY, CO ANTRIM, United Kingdom

Pfizer Investigational Site, HASTINGS, EAST SUSSEX, United Kingdom

Pfizer Investigational Site, HIGH VALLEYFIELD, FIFE, United Kingdom

Pfizer Investigational Site, Rutherglen, Glasgow, United Kingdom

Pfizer Investigational Site, LESLIE, FIFE, Glenrotheshire, United Kingdom

Pfizer Investigational Site, Unknown, United Kingdom

Pfizer Investigational Site, MADRID, Spain

Pfizer Investigational Site, MARBELLA, Spain

Pfizer Investigational Site, FERRARA, Italy

Pfizer Investigational Site, GROSSETO, Italy

Pfizer Investigational Site, SALERNO, Italy

Pfizer Investigational Site, AVILA, Spain

Pfizer Investigational Site, CHIETI, Italy

Pfizer Investigational Site, TARRAGONA, Spain

Pfizer Investigational Site, HUELVA, Spain

Pfizer Investigational Site, 37900, Spain

Pfizer Investigational Site, VALENCIA, Spain

Pfizer Investigational Site, JEREZ DE LA FRONTERA, Spain

Pfizer Investigational Site, PALERMO, Italy

Pfizer Investigational Site, SIENA, Italy

Pfizer Investigational Site, TORINO, Italy

Pfizer Investigational Site, GRANADA, Spain

Pfizer Investigational Site, BELLUNO, Italy

Pfizer Investigational Site, BARI, Italy

Pfizer Investigational Site, SEVILLA, Spain

Pfizer Investigational Site, SASSARI, Italy

Pfizer Investigational Site, SAN DONATO MILANESE, Italy

Pfizer Investigational Site, PERUGIA, Italy

Pfizer Investigational Site, BOLOGNA, Italy

Pfizer Investigational Site, CATANIA, Italy

Pfizer Investigational Site, BATH, United Kingdom

Pfizer Investigational Site, VENEZIA, Italy

Pfizer Investigational Site, PRATO, Italy

Pfizer Investigational Site, SAVONA, Italy

Pfizer Investigational Site, NOVARA, Italy

Pfizer Investigational Site, QUEBEC, Canada

Pfizer Investigational Site, BOLZANO, Italy

Pfizer Investigational Site, ROMA, Italy

Pfizer Investigational Site, NAPOLI, Italy

Pfizer Investigational Site, FOGGIA, Italy

Pfizer Investigational Site, FIRENZE, Italy

Pfizer Investigational Site, ASTI, Italy

Pfizer Investigational Site, POTENZA, Italy

Pfizer Investigational Site, PALERMO, Italy

Pfizer Investigational Site, BARCELONA, Spain

Pfizer Investigational Site, SUNBURY ON THAMES, MIDDLESEX, United Kingdom

Pfizer Investigational Site, WINNIPEG, Manitoba, Canada

Pfizer Investigational Site, BRANDON, Manitoba, Canada

Pfizer Investigational Site, Mississauga, Ontario, Cameroon

Pfizer Investigational Site, NORTH YORK, Ontario, Canada

Pfizer Investigational Site, OSHAWA, Ontario, Canada

Pfizer Investigational Site, NIAGARA FALLS, Ontario, Canada

Pfizer Investigational Site, WESTON, Ontario, Canada

Pfizer Investigational Site, SIMCOE, Ontario, Canada

Pfizer Investigational Site, BURLINGTON, Ontario, Canada

Pfizer Investigational Site, BRAMPTON, Ontario, Canada

Pfizer Investigational Site, MISSISSAUGA, Ontario, Canada

Pfizer Investigational Site, WHITBY, Ontario, Canada

Pfizer Investigational Site, REXDALE, Ontario, Canada

Pfizer Investigational Site, AJAX, Ontario, Canada

Pfizer Investigational Site, TORONTO, Ontario, Canada

Pfizer Investigational Site, WILLOWDALE, Ontario, Canada

Pfizer Investigational Site, ORILLIA, Ontario, Canada

Pfizer Investigational Site, THUNDER BAY, Ontario, Canada

Pfizer Investigational Site, SCARBOROUGH, Ontario, Canada

Pfizer Investigational Site, SARNIA, Ontario, Canada

Pfizer Investigational Site, ETOBICOKE, Ontario, Canada

Pfizer Investigational Site, CAMBRIDGE, Ontario, Canada

Pfizer Investigational Site, CORNWALL, Ontario, Canada

Pfizer Investigational Site, MONTREAL, Quebec, Canada

Pfizer Investigational Site, COWANSVILLE, Quebec, Canada

Pfizer Investigational Site, ST-GEORGES (BEAUCE), Quebec, Canada

Pfizer Investigational Site, THETFORD MINES, Quebec, Canada

Pfizer Investigational Site, ST. LAMBERT, Quebec, Canada

Pfizer Investigational Site, CHICOUTIMI, Quebec, Canada

Pfizer Investigational Site, DRUMMONDVILLE, Quebec, Canada

Pfizer Investigational Site, REPENTIGNY, Quebec, Canada

Pfizer Investigational Site, LAVAL, Quebec, Canada

Pfizer Investigational Site, NEWPORT, Quebec, Canada

Pfizer Investigational Site, SAINT HYACINTHE, Quebec, Canada

Pfizer Investigational Site, Joliette, Quebec, Canada

Pfizer Investigational Site, VAUDREUIL, Quebec, Canada

Pfizer Investigational Site, POINTE CLAIRE, Quebec, Canada

Pfizer Investigational Site, SAINTE FOY, Quebec, Canada

Pfizer Investigational Site, LEVIS, Quebec, Canada

Pfizer Investigational Site, Sherbrooke, Quebec, Canada

Pfizer Investigational Site, MARIA, Quebec, Canada

Pfizer Investigational Site, FROME, SOMERSET, United Kingdom

Pfizer Investigational Site, EAST HORSLEY, SURREY, United Kingdom

Pfizer Investigational Site, ADDLESTONE, SURREY, United Kingdom

Pfizer Investigational Site, SASKATOON, Saskatchewan, Canada

Pfizer Investigational Site, BARRY, South Glamorgan, United Kingdom

Pfizer Investigational Site, DONCASTER, South Yorkshire, United Kingdom

Pfizer Investigational Site, STAIRFOOT, BARNSLEY, South Yorkshire, United Kingdom

Pfizer Investigational Site, GALDAKAO, VIZCAYA, Spain

Pfizer Investigational Site, ATHERSTONE, WARKS, United Kingdom

Pfizer Investigational Site, POUND HILL, CRAWLEY, WEST SUSSEX, United Kingdom

Pfizer Investigational Site, CHIPPENHAM, WILTS, United Kingdom

Pfizer Investigational Site, TROWBRIDGE, WILTSHIRE, United Kingdom

Pfizer Investigational Site, BALSALL COMMON, West Midlands, United Kingdom

Pfizer Investigational Site, SHEFFIELD, YORKSHIRE, United Kingdom

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting:

Starting date: January 2003
Ending date: February 2004
Last updated: April 4, 2007