Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets

Diabetes Mellitus, Type 2 Clinical Trial

— ACTFAST 2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442325
• Other study ID #: A2581095
• Status: Completed
• Phase: Phase 4
• Start date: January 2003
• Est. completion date: February 2004

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. 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

Related Conditions & MeSH terms

• Arteriosclerosis
• Cerebrovascular Accident
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Stroke
• Vascular Diseases

Intervention

Drug:
• Atorvastatin (Lipitor)

Locations

Country	Name	City	State
	Pfizer Investigational Site
Greece	Pfizer Investigational Site	Ioannina
Greece	Pfizer Investigational Site	Kallithea, Athens
Greece	Pfizer Investigational Site	Pireaus
Greece	Pfizer Investigational Site	Thessaloniki
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Gyula
Hungary	Pfizer Investigational Site	Kecskemet
Hungary	Pfizer Investigational Site	Nyíregyháza
Hungary	Pfizer Investigational Site	Szekszárd
Ireland	Pfizer Investigational Site	Cork
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Dublin 8
Ireland	Pfizer Investigational Site	Galway
Ireland	Pfizer Investigational Site	Gorey	Wexford
Ireland	Pfizer Investigational Site	Tallaght	Dublin
Ireland	Pfizer Investigational Site	Tullamore	CO. Offlay
Poland	Pfizer Investigational Site	Czestochowa
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Wroclaw
Poland	Pfizer Investigational Site	Zabrze
Portugal	Pfizer Investigational Site	Aveiro
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Vila Franca de Xira
Russian Federation	Pfizer Investigational Site	Moscow
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Kosice
Switzerland	Pfizer Investigational Site	Bern
Switzerland	Pfizer Investigational Site	Genève
Switzerland	Pfizer Investigational Site	Mendrisio
Switzerland	Pfizer Investigational Site	Zürich

Sponsors (1)

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

Countries where clinical trial is conducted

Greece,  Hungary,  Ireland,  Poland,  Portugal,  Russian Federation,  Slovakia,  Switzerland, 

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. Change from baseline in apol

External Links

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