Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00647543

Purpose

The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.

Condition	Intervention	Phase
Dyslipidemias	Drug: Atorvastatin	Phase IV

MedlinePlus related topics: Cholesterol

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Eight-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, And 40 Mg

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events and laboratory test changes [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: Yes ]
Percentage of patients who achieved LDL-C target [ Time Frame: Weeks 2 and 4, and Week 8 with 1 step titration ] [ Designated as safety issue: No ]
Change and percent change from baseline in LDL-C [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C) [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
Change and percent change from baseline in LDL/HDL ratio [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
Change and percent change from baseline in total cholesterol [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
Change and percent change from baseline in triglycerides [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]

Arms	Assigned Interventions
High Risk: Experimental	Drug: Atorvastatin Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Low Risk: Experimental	Drug: Atorvastatin Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Medium Risk: Experimental	Drug: Atorvastatin Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.

Eligibility

Criteria

Inclusion Criteria:

Dyslipidemic patients who were eligible for lipid lowering therapy
Willingness to follow study diet for 1 month prior to screening and for the duration of the study

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647543

Locations

Thailand
Pfizer Investigational Site
Chiang Mai, Thailand, 50200
Pfizer Investigational Site
BANGKOK, Thailand, 10700
Pfizer Investigational Site
Bangkok, Thailand, 10700
Pfizer Investigational Site
Bangkok, Thailand, 10400
Thailand, Bangkok
Pfizer Investigational Site
Unknown, Bangkok, Thailand, 10330
Pfizer Investigational Site
Unknown, Bangkok, Thailand
Pfizer Investigational Site
Unknown, Bangkok, Thailand, 10400

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2581111
Study First Received:	March 26, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00647543
Health Authority:	Thailand: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metabolic disorder
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009