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NCT00442845 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00442845
Other study ID # A2581087
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2003
Est. completion date February 2004

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 2080
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin (Lipitor)

Locations
Country Name City State
Pfizer Investigational Site
Cameroon Pfizer Investigational Site Mississauga Ontario
Canada Pfizer Investigational Site Ajax Ontario
Canada Pfizer Investigational Site Brampton Ontario
Canada Pfizer Investigational Site Brandon Manitoba
Canada Pfizer Investigational Site Burlington Ontario
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Cambridge Ontario
Canada Pfizer Investigational Site Campbell River British Columbia
Canada Pfizer Investigational Site Chicoutimi Quebec
Canada Pfizer Investigational Site Cornwall Ontario
Canada Pfizer Investigational Site Cowansville Quebec
Canada Pfizer Investigational Site Drummondville Quebec
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Etobicoke Ontario
Canada Pfizer Investigational Site Joliette Quebec
Canada Pfizer Investigational Site Laval Quebec
Canada Pfizer Investigational Site Levis Quebec
Canada Pfizer Investigational Site Maple Ridge British Columbia
Canada Pfizer Investigational Site Maria Quebec
Canada Pfizer Investigational Site Medicine Hat Alberta
Canada Pfizer Investigational Site Mississauga Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Nanaimo British Columbia
Canada Pfizer Investigational Site New Westminster British Columbia
Canada Pfizer Investigational Site Newport Quebec
Canada Pfizer Investigational Site Niagara Falls Ontario
Canada Pfizer Investigational Site North York Ontario
Canada Pfizer Investigational Site Orillia Ontario
Canada Pfizer Investigational Site Oshawa Ontario
Canada Pfizer Investigational Site Pointe Claire Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Red Deer Alberta
Canada Pfizer Investigational Site Repentigny Quebec
Canada Pfizer Investigational Site Rexdale Ontario
Canada Pfizer Investigational Site Richmond British Columbia
Canada Pfizer Investigational Site Saint Hyacinthe Quebec
Canada Pfizer Investigational Site Sainte Foy Quebec
Canada Pfizer Investigational Site Sarnia Ontario
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Scarborough Ontario
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site Simcoe Ontario
Canada Pfizer Investigational Site St-georges (beauce) Quebec
Canada Pfizer Investigational Site St. Lambert Quebec
Canada Pfizer Investigational Site Surrey British Columbia
Canada Pfizer Investigational Site Thetford Mines Quebec
Canada Pfizer Investigational Site Thunder Bay Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Vaudreuil Quebec
Canada Pfizer Investigational Site Vernon British Columbia
Canada Pfizer Investigational Site Victoria British Columbia
Canada Pfizer Investigational Site Weston Ontario
Canada Pfizer Investigational Site Whitby Ontario
Canada Pfizer Investigational Site Willowdale Ontario
Canada Pfizer Investigational Site Winnipeg Manitoba
Italy Pfizer Investigational Site Asti
Italy Pfizer Investigational Site Bari
Italy Pfizer Investigational Site Belluno
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Bolzano
Italy Pfizer Investigational Site Catania
Italy Pfizer Investigational Site Chieti
Italy Pfizer Investigational Site Ferrara
Italy Pfizer Investigational Site Firenze
Italy Pfizer Investigational Site Foggia
Italy Pfizer Investigational Site Grosseto
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Novara
Italy Pfizer Investigational Site Palermo
Italy Pfizer Investigational Site Perugia
Italy Pfizer Investigational Site Potenza
Italy Pfizer Investigational Site Prato
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Salerno
Italy Pfizer Investigational Site San Donato Milanese
Italy Pfizer Investigational Site Sassari
Italy Pfizer Investigational Site Savona
Italy Pfizer Investigational Site Siena
Italy Pfizer Investigational Site Somma Lombardo (va)
Italy Pfizer Investigational Site Torino
Italy Pfizer Investigational Site Tricase (le)
Italy Pfizer Investigational Site Venezia
Italy Pfizer Investigational Site Vimercate (mi)
Spain Pfizer Investigational Site Avila
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Galdakao Vizcaya
Spain Pfizer Investigational Site Girona Cataluna
Spain Pfizer Investigational Site Granada
Spain Pfizer Investigational Site Hospitalet de Llobregat Barcelona
Spain Pfizer Investigational Site Huelva
Spain Pfizer Investigational Site Jerez de La Frontera
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Marbella
Spain Pfizer Investigational Site Sevilla
Spain Pfizer Investigational Site Tarragona
Spain Pfizer Investigational Site Valencia
United Kingdom Pfizer Investigational Site Addlestone Surrey
United Kingdom Pfizer Investigational Site Atherstone Warks
United Kingdom Pfizer Investigational Site Aylesbury Buckinghamshire
United Kingdom Pfizer Investigational Site Balsall Common WEST Midlands
United Kingdom Pfizer Investigational Site Barry South Glamorgan
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Chippenham Wilts
United Kingdom Pfizer Investigational Site Doncaster South Yorkshire
United Kingdom Pfizer Investigational Site East Horsley Surrey
United Kingdom Pfizer Investigational Site ELY Cambs
United Kingdom Pfizer Investigational Site Frome Somerset
United Kingdom Pfizer Investigational Site Hastings EAST Sussex
United Kingdom Pfizer Investigational Site High Valleyfield Fife
United Kingdom Pfizer Investigational Site Leslie, FIFE Glenrotheshire
United Kingdom Pfizer Investigational Site Newtonabbey CO Antrim
United Kingdom Pfizer Investigational Site Newtonabbey Belfast
United Kingdom Pfizer Investigational Site Peterborough Cambs
United Kingdom Pfizer Investigational Site Pound Hill, Crawley WEST Sussex
United Kingdom Pfizer Investigational Site Rutherglen Glasgow
United Kingdom Pfizer Investigational Site Sheffield Yorkshire
United Kingdom Pfizer Investigational Site Stairfoot, Barnsley South Yorkshire
United Kingdom Pfizer Investigational Site Sunbury on Thames Middlesex
United Kingdom Pfizer Investigational Site Trowbridge Wiltshire

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Cameroon,  Canada,  Italy,  Spain,  United Kingdom, 

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