Back to resultsA Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol (LA ATGOAL)
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
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:
- Triglycerides less than or equal to 400 mg/dL
- Hemoglobin A1c >10%
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
High Risk
Low Risk
Medium Risk
Arm Description
Outcomes
Primary Outcome Measures
Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level
Secondary Outcome Measures
Percentage of patients achieving LDL goal at 2 and 4 weeks
Lipid changes at week 4 & 8
Full Information
NCT ID
NCT00645151
First Posted
March 25, 2008
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00645151
Brief Title
A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol
Acronym
LA ATGOAL
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the percentage of patients who would reach a cholesterol goal after atorvastatin treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
512 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Risk
Arm Type
Experimental
Arm Title
Low Risk
Arm Type
Experimental
Arm Title
Medium Risk
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of patients achieving LDL goal at 2 and 4 weeks
Time Frame
Weeks 2 and 4
Title
Lipid changes at week 4 & 8
Time Frame
Weeks 4 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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:
Triglycerides less than or equal to 400 mg/dL
Hemoglobin A1c >10%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80540-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-170
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São José
State/Province
SC
ZIP/Postal Code
88103-460
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP/Brazil
ZIP/Postal Code
04039-001
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Campinas
State/Province
SP
ZIP/Postal Code
13012-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Campinas
State/Province
SP
ZIP/Postal Code
13059-740
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04012-180
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São José do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
ZIP/Postal Code
20550-030
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Barranquilla
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogotá, C/marca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cali, Valle
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Quito
State/Province
Pichincha / Ecuador
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Pfizer Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44290
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64410
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Durango
ZIP/Postal Code
34300
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Panama
Country
Panama
Facility Name
Pfizer Investigational Site
City
Dtto. Federal
State/Province
Caracas
ZIP/Postal Code
1020
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Dtto Federal
ZIP/Postal Code
1061
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Dtto Federal
ZIP/Postal Code
1081
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Edo. Miranda
ZIP/Postal Code
1061
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
ZIP/Postal Code
1020
Country
Venezuela
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581104&StudyName=A%20Study%20Of%20The%20Efficacy%20Of%20Lipitor%20In%20Lowering%20Cholesterol%20In%20Latin%20American%20Patients%20With%20High%20Cholesterol
Description
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Learn more about this trial
A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol
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