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A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol (LA ATGOAL)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645151
First received: March 25, 2008
Last updated: April 8, 2008
Last verified: April 2008
  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 4

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

Resource links provided by NLM:


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 ]

Enrollment: 512
Study Start Date: April 2004
Study Completion Date: February 2005
Arms Assigned Interventions
Experimental: High Risk 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.
Experimental: Low Risk 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.
Experimental: Medium Risk 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • Triglycerides less than or equal to 400 mg/dL
  • Hemoglobin A1c >10%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Pfizer Investigational Site
Belo Horizonte, MG, Brazil
Pfizer Investigational Site
Curitiba, PR, Brazil, 80540-010
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-170
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
São José, SC, Brazil, 88103-460
Pfizer Investigational Site
São Paulo, SP/Brazil, Brazil, 04039-001
Pfizer Investigational Site
Campinas, SP, Brazil, 13059-740
Pfizer Investigational Site
Campinas, SP, Brazil, 13012-000
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04012-180
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01244-030
Pfizer Investigational Site
São José do Rio Preto, SP, Brazil, 15090-000
Pfizer Investigational Site
São Paulo, SP, Brazil
Pfizer Investigational Site
Rio de Janeiro, Brazil, 20550-030
Chile
Pfizer Investigational Site
Santiago, Región Metropolitana, Chile
Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Bogotá, Cundinamarca, Colombia
Pfizer Investigational Site
Barranquilla, Colombia
Pfizer Investigational Site
Bogotá, C/marca, Colombia
Pfizer Investigational Site
Cali, Valle, Colombia
Ecuador
Pfizer Investigational Site
Quito, Pichincha / Ecuador, Ecuador
Guatemala
Pfizer Investigational Site
Guatemala, Guatemala, 01015
Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44290
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45200
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64060
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64410
Pfizer Investigational Site
Chihuahua, Mexico, 31238
Pfizer Investigational Site
Durango, Mexico, 34300
Panama
Pfizer Investigational Site
Panama, Panama
Venezuela
Pfizer Investigational Site
Dtto. Federal, Caracas, Venezuela, 1020
Pfizer Investigational Site
Caracas, Dtto Federal, Venezuela, 1081
Pfizer Investigational Site
Caracas, Dtto Federal, Venezuela, 1061
Pfizer Investigational Site
Caracas, Edo. Miranda, Venezuela, 1061
Pfizer Investigational Site
Caracas, Venezuela, 1020
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014