Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00442325

Purpose

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)

Condition	Intervention	Phase
Coronary Arteriosclerosis Diabetes Mellitus, Type 2 Cerebrovascular Accident Dyslipidemia Peripheral Vascular Disease	Drug: Atorvastatin (Lipitor)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Dose Comparison Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Cholest-5-en-3-ol (3beta)- Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	595
Study Start Date:	January 2003
Estimated Study Completion Date:	February 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442325

Show 35 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	A2581095
Study First Received:	February 28, 2007
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00442325 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Myocardial Ischemia
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Dyslipidemias
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Heart Diseases
Metabolic Diseases

Antilipemic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coronary Disease
Diabetes Mellitus, Type 2
Brain Infarction
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on March 18, 2010