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

NCT ID: NCT00645151

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-02-28

Brief Summary

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

Detailed Description

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Conditions

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Dyslipidemias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Risk

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

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.

Low Risk

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

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.

Medium Risk

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Site Status

Pfizer Investigational Site

Curitiba, Paraná, Brazil

Site Status

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Pfizer Investigational Site

São José, Santa Catarina, Brazil

Site Status

Pfizer Investigational Site

São Paulo, SP/Brazil, Brazil

Site Status

Pfizer Investigational Site

Campinas, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Campinas, São Paulo, Brazil

Site Status

Pfizer Investigational Site

São José do Rio Preto, São Paulo, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Rio de Janeiro, , Brazil

Site Status

Pfizer Investigational Site

Santiago, Santiago Metropolitan, Chile

Site Status

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Site Status

Pfizer Investigational Site

Bogotá, Cundinamarca, Colombia

Site Status

Pfizer Investigational Site

Barranquilla, , Colombia

Site Status

Pfizer Investigational Site

Bogotá, C/marca, , Colombia

Site Status

Pfizer Investigational Site

Cali, Valle, , Colombia

Site Status

Pfizer Investigational Site

Quito, Pichincha / Ecuador, Ecuador

Site Status

Pfizer Investigational Site

Guatemala City, , Guatemala

Site Status

Pfizer Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

Pfizer Investigational Site

Zapopan, Jalisco, Mexico

Site Status

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Pfizer Investigational Site

Chihuahua City, , Mexico

Site Status

Pfizer Investigational Site

Durango, , Mexico

Site Status

Pfizer Investigational Site

Panama City, , Panama

Site Status

Pfizer Investigational Site

Caracas, Dtto Federal, Venezuela

Site Status

Pfizer Investigational Site

Caracas, Dtto Federal, Venezuela

Site Status

Pfizer Investigational Site

Caracas, Edo. Miranda, Venezuela

Site Status

Pfizer Investigational Site

Dtto. Federal, Miranda, Venezuela

Site Status

Pfizer Investigational Site

Caracas, , Venezuela

Site Status

Countries

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Brazil Chile Colombia Ecuador Guatemala Mexico Panama Venezuela

Related Links

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Other Identifiers

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A2581104

Identifier Type: -

Identifier Source: org_study_id

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