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

Phase 4

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: Atorvastatin

• Registration Number: NCT00645151
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2005-02
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 512

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Risk	Atorvastatin	-
High Risk	Atorvastatin	-
Medium Risk	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level	Week 8

Secondary Outcome Measures

Name	Time	Method
Percentage of patients achieving LDL goal at 2 and 4 weeks	Weeks 2 and 4
Lipid changes at week 4 & 8	Weeks 4 and 8

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇻🇪 Caracas, Venezuela