A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00645151

Purpose

The purpose of this study is to determine the percentage of patients who would reach a cholesterol goal after atorvastatin treatment.

Condition	Intervention	Phase
Dyslipidemias	Drug: Atorvastatin	Phase IV

MedlinePlus related topics: Cholesterol

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

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 Subjects Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg (Latin American Atorvastatin ATGOAL Study)

Further study details as provided by Pfizer:

Primary Outcome Measures:

Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients achieving LDL goal at 2 and 4 weeks [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Lipid changes at week 4 & 8 [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]

Arms	Assigned Interventions
High Risk: Experimental	Drug: Atorvastatin Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
Low Risk: Experimental	Drug: Atorvastatin Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
Medium Risk: Experimental	Drug: Atorvastatin Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.

Eligibility

Criteria

Inclusion Criteria:

Patients with high cholesterol eligible for treatment with baseline LDL-C level of less than or equal to 220 mg/dL
Willingness to follow diet

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645151

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2581104
Study First Received:	March 25, 2008
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00645151
Health Authority:	Brazil: Ministry of Health

Study placed in the following topic categories:

Calcium, Dietary
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