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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

512

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients achieving LDL goal at 2 and 4 weeks
Time Frame: Weeks 2 and 4
Weeks 2 and 4
Lipid changes at week 4 & 8
Time Frame: Weeks 4 and 8
Weeks 4 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (ACTUAL)

February 1, 2005

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (ESTIMATE)

March 27, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2581104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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