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
• Status: Completed
• Phase: Phase 4
• Start date: April 2004
• Est. completion date: February 2005

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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
• 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%

Related Conditions & MeSH terms

• Dyslipidemias

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

External Links

•   To obtain contact information for a study center near you, click here.