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

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

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)

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.

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 apol

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, TULLAMORE, CO. OFFLAY, Ireland

Pfizer Investigational Site, TALLAGHT, DUBLIN, Ireland

Pfizer Investigational Site, PORTO, Portugal

Pfizer Investigational Site, KECSKEMET, Hungary

Pfizer Investigational Site, BUDAPEST, Hungary

Pfizer Investigational Site, WROCLAW, Poland

Pfizer Investigational Site, Warszawa, Poland

Pfizer Investigational Site, KALLITHEA, ATHENS, Greece

Pfizer Investigational Site, AVEIRO, Portugal

Pfizer Investigational Site, Bratislava, Slovakia

Pfizer Investigational Site, SZEKSZÁRD, Hungary

Pfizer Investigational Site, NYÍREGYHÁZA, Hungary

Pfizer Investigational Site, DUBLIN, Ireland

Pfizer Investigational Site, GALWAY, Ireland

Pfizer Investigational Site, MENDRISIO, Switzerland

Pfizer Investigational Site, BERN, Switzerland

Pfizer Investigational Site, ZÜRICH, Switzerland

Pfizer Investigational Site, Unknown, Portugal

Pfizer Investigational Site, WARSZAWA, Poland

Pfizer Investigational Site, IOANNINA, Greece

Pfizer Investigational Site, ZABRZE, Poland

Pfizer Investigational Site, CZESTOCHOWA, Poland

Pfizer Investigational Site, VILA FRANCA DE XIRA, Portugal

Pfizer Investigational Site, CORK, Ireland

Pfizer Investigational Site, Unknown, Hungary

Pfizer Investigational Site, Unknown, Ireland

Pfizer Investigational Site, LISBOA, Portugal

Pfizer Investigational Site, PIREAUS, Greece

Pfizer Investigational Site, GENÈVE, Switzerland

Pfizer Investigational Site, POZNAN, Poland

Pfizer Investigational Site, GYULA, Hungary

Pfizer Investigational Site, DUBLIN 8, Ireland

Pfizer Investigational Site, THESSALONIKI, Greece

Pfizer Investigational Site, MOSCOW, Russian Federation

Pfizer Investigational Site, Kosice, Slovakia

Pfizer Investigational Site, GOREY, WEXFORD, Ireland

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