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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.232 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

232

Conditions

Dyslipidemias

Interventions

AtorvastatinDRUG

In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.

AtorvastatinDRUG

In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (17)

Pfizer Investigational Site

Antwerp, Belgium

Pfizer Investigational Site

Brasschaat, Belgium

Pfizer Investigational Site

Outcomes

Primary Outcomes

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

Time frame: Week 12

Secondary Outcomes

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

Time frame: Weeks 6 and 12

Proportion of subjects across different LDL-C strata who achieved LDL-C target

Time frame: Week 6

Proportion of diabetic subjects in entire group who achieved LDL-C target

Time frame: Week 12

Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)

Time frame: Week 12

Change from baseline in hemoglobin A1c levels

Time frame: Week 12

Adverse events and laboratory test changes

Time frame: Weeks 6 and 12

Proportion of subjects in entire group who achieved LDL-C target

Time frame: Week 6

Data from ClinicalTrials.gov

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