A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644709

Purpose

A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL

Condition	Intervention	Phase
Dyslipidemias	Drug: Atorvastatin	Phase IV

MedlinePlus related topics: Cholesterol Heart Diseases

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level

Further study details as provided by Pfizer:

Primary Outcome Measures:

Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels [ Time Frame: Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study ] [ Designated as safety issue: No ]
Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study [ Time Frame: Baseline and Weeks 17, 34, and 52 ] [ Designated as safety issue: No ]
Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Adverse events and laboratory test changes [ Time Frame: Weeks 17, 34, and 52 ] [ Designated as safety issue: Yes ]
Achievement of LDL-C target [ Time Frame: Weeks 17 and 34 ] [ Designated as safety issue: No ]
Achievement of LDL-C target by diabetic patients [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment:	196
Study Start Date:	September 2003
Study Completion Date:	March 2005

Arms	Assigned Interventions
Arm A: Experimental	Drug: Atorvastatin Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completion of base study
Dyslipidemia and at high risk of CHD

Exclusion Criteria:

Impaired liver function
Gastrointestinal disease that could limit drug absorption

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644709

Locations

Belgium
Pfizer Investigational Site
LA LOUVIÈRE, Belgium, 7100
Pfizer Investigational Site
ROESELARE, Belgium, 8800
Pfizer Investigational Site
WILRIJK, Belgium, 2610
Pfizer Investigational Site
MECHELEN, Belgium, 2800
Pfizer Investigational Site
BRUSSELS, Belgium, 1180
Pfizer Investigational Site
MENEN, Belgium, 8930
Pfizer Investigational Site
WINGENE, Belgium, 8750
Pfizer Investigational Site
GILLY (CHARLEROI), Belgium, 6060
Pfizer Investigational Site
MERKSEM, Belgium, 2170
Pfizer Investigational Site
GENK, Belgium, B-3600
Pfizer Investigational Site
MORTSEL, Belgium, 2640
Pfizer Investigational Site
ANTWERPEN, Belgium, 2018
Pfizer Investigational Site
GENT, Belgium, 9000
Pfizer Investigational Site
BRASSCHAAT, Belgium, 2930
Pfizer Investigational Site
SERAING, Belgium, 4100

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More 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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2581112
Study First Received:	March 25, 2008
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00644709
Health Authority:	Belgium: Ministry of Health

Study placed in the following topic categories:

Coronary Disease
Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Metabolic disorder
Atorvastatin
Dyslipidemias
Coronary Artery Disease
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009