Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST 2)

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00442325

First received: February 28, 2007

Last updated: October 24, 2007

Last verified: April 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

February 28, 2007

Last Updated Date

October 24, 2007

Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00442325 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Arteriosclerosis
Diabetes Mellitus, Type 2
Cerebrovascular Accident
Dyslipidemia
Peripheral Vascular Disease

Intervention ^ICMJE

Drug: Atorvastatin (Lipitor)

Study Arm (s)

Not Provided

Publications *

Farsang C, Athyros V, Gaw A; ACTFAST-2 investigators and Steering Committee members. A multicentre, open study to assess the effect of individualizing starting doses of atorvastatin according to baseline LDL-C levels on achieving cholesterol targets: the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST-2) study. Curr Med Res Opin. 2007 Aug;23(8):1945-56.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

595

Completion Date

February 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00442325

Other Study ID Numbers ^ICMJE

A2581095

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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