ClinicalTrials.gg
CompletedNCT00645151LA ATGOALUpdated Feb 18, 2021

A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol

A Phase 4 interventional study of Atorvastatin and Atorvastatin in Dyslipidemias, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 33 sites in 8 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (part of Viatris Inc.) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
512
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Dyslipidemias

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03

In context

Dyslipidemias

1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.

This study's enrollment of 512 is above the median of 100 across 986 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 434 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

First submitted before Pfizer's Upjohn has merged with Mylan to form Viatris Inc. became part of Viatris Inc..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Triglycerides less than or equal to 400 mg/dL
  • >10%
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
512 participants (actual)

Study arms

  • Experimental
    High Risk

    Drug: Atorvastatin

  • Experimental
    Low Risk

    Drug: Atorvastatin

  • Experimental
    Medium Risk

    Drug: Atorvastatin

Interventions

  • 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.

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level

    Time frame: Week 8

Secondary outcomes

  1. Percentage of patients achieving LDL goal at 2 and 4 weeks

    Time frame: Weeks 2 and 4

  2. Lipid changes at week 4 & 8

    Time frame: Weeks 4 and 8

07

Study locations

33 sites
  • Pfizer Investigational Site
    Belo Horizonte, MG, Brazil
  • Pfizer Investigational Site
    Curitiba, PR 80540-010, Brazil
  • Pfizer Investigational Site
    Porto Alegre, RS 90035-170, Brazil
  • Pfizer Investigational Site
    Porto Alegre, RS 90610-000, Brazil
  • Pfizer Investigational Site
    São José, SC 88103-460, Brazil
  • Pfizer Investigational Site
    São Paulo, SP/Brazil 04039-001, Brazil
  • Pfizer Investigational Site
    Campinas, SP 13012-000, Brazil
  • Pfizer Investigational Site
    Campinas, SP 13059-740, Brazil
  • Pfizer Investigational Site
    Sao Paulo, SP 01244-030, Brazil
  • Pfizer Investigational Site
    Sao Paulo, SP 04012-180, Brazil
  • Pfizer Investigational Site
    São José do Rio Preto, SP 15090-000, Brazil
  • Pfizer Investigational Site
    São Paulo, SP, Brazil
  • Pfizer Investigational Site
    Rio de Janeiro, 20550-030, Brazil
  • Pfizer Investigational Site
    Santiago, Región Metropolitana, Chile
  • 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
  • Pfizer Investigational Site
    Quito, Pichincha / Ecuador, Ecuador
  • Pfizer Investigational Site
    Guatemala, 01015, Guatemala
  • Pfizer Investigational Site
    Guadalajara, Jalisco 44290, Mexico
  • Pfizer Investigational Site
    Zapopan, Jalisco 45200, Mexico
  • Pfizer Investigational Site
    Monterrey, Nuevo Leon 64060, Mexico
  • Pfizer Investigational Site
    Monterrey, Nuevo Leon 64410, Mexico
  • Pfizer Investigational Site
    Chihuahua, 31238, Mexico
  • Pfizer Investigational Site
    Durango, 34300, Mexico
  • Pfizer Investigational Site
    Panama, Panama
  • Pfizer Investigational Site
    Dtto. Federal, Caracas 1020, Venezuela
  • Pfizer Investigational Site
    Caracas, Dtto Federal 1061, Venezuela
  • Pfizer Investigational Site
    Caracas, Dtto Federal 1081, Venezuela
  • Pfizer Investigational Site
    Caracas, Edo. Miranda 1061, Venezuela
  • Pfizer Investigational Site
    Caracas, 1020, Venezuela
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2004 and a completion of Feb 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2008
First posted
Mar 27, 2008
Start
Apr 2004
CompletionActual
Feb 2005
Last update
Feb 18, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00645151
Responsible party
Sponsor
First posted
Mar 27, 2008
Start date
Apr 2004
Completion
Feb 2005
Last update
Feb 18, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Atorvastatin

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