A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol

Phase 4

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: Atorvastatin

• Registration Number: NCT00644670
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL \<115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2004-03
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• 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: 232

Inclusion Criteria

• Dyslipidemia
• At a high risk for coronary heart disease

Exclusion Criteria

• Use of higher than usual maintenance doses of statin drugs at screening
• Uncontrolled diabetes or high blood pressure
• Impaired liver function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Previous Treatment with a Usual Maintenance Dose of a Statin	Atorvastatin	-
Statin-Naive	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL	Week 12

Secondary Outcome Measures

Name	Time	Method
Mean percent change from baseline in LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, triglycerides, and apolipoprotein B for statin-naive patients	Weeks 6 and 12
Proportion of subjects across different LDL-C strata who achieved LDL-C target	Week 6
Proportion of diabetic subjects in entire group who achieved LDL-C target	Week 12
Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)	Week 12
Change from baseline in hemoglobin A1c levels	Week 12
Adverse events and laboratory test changes	Weeks 6 and 12
Proportion of subjects in entire group who achieved LDL-C target	Week 6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Wingene, Belgium