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NCT00645151 Clinical Trial

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

Dyslipidemias Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00645151
Other study ID # A2581104
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2004
Est. completion date February 2005

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 512
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.

Locations
Country Name City State
Brazil Pfizer Investigational Site Belo Horizonte MG
Brazil Pfizer Investigational Site Campinas SP
Brazil Pfizer Investigational Site Campinas SP
Brazil Pfizer Investigational Site Curitiba PR
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Rio de Janeiro
Brazil Pfizer Investigational Site São José SC
Brazil Pfizer Investigational Site São José do Rio Preto SP
Brazil Pfizer Investigational Site Sao Paulo SP
Brazil Pfizer Investigational Site Sao Paulo SP
Brazil Pfizer Investigational Site São Paulo SP/Brazil
Brazil Pfizer Investigational Site São Paulo SP
Chile Pfizer Investigational Site Santiago Región Metropolitana
Colombia Pfizer Investigational Site Barranquilla
Colombia Pfizer Investigational Site Bogota Cundinamarca
Colombia Pfizer Investigational Site Bogotá Cundinamarca
Colombia Pfizer Investigational Site Bogotá, C/marca
Colombia Pfizer Investigational Site Cali, Valle
Ecuador Pfizer Investigational Site Quito Pichincha / Ecuador
Guatemala Pfizer Investigational Site Guatemala
Mexico Pfizer Investigational Site Chihuahua
Mexico Pfizer Investigational Site Durango
Mexico Pfizer Investigational Site Guadalajara Jalisco
Mexico Pfizer Investigational Site Monterrey Nuevo Leon
Mexico Pfizer Investigational Site Monterrey Nuevo Leon
Mexico Pfizer Investigational Site Zapopan Jalisco
Panama Pfizer Investigational Site Panama
Venezuela Pfizer Investigational Site Caracas Dtto Federal
Venezuela Pfizer Investigational Site Caracas Dtto Federal
Venezuela Pfizer Investigational Site Caracas Edo. Miranda
Venezuela Pfizer Investigational Site Caracas
Venezuela Pfizer Investigational Site Dtto. Federal Caracas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Brazil,  Chile,  Colombia,  Ecuador,  Guatemala,  Mexico,  Panama,  Venezuela, 

Outcome
Type Measure Description Time frame Safety issue
Primary Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level Week 8
Secondary Percentage of patients achieving LDL goal at 2 and 4 weeks Weeks 2 and 4
Secondary Lipid changes at week 4 & 8 Weeks 4 and 8
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