A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.196 enrolled

Overview

A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of \<115 mg/dL

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

196

Conditions

Dyslipidemias

Interventions

AtorvastatinDRUG

Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Completion of base study * Dyslipidemia and at high risk of CHD Exclusion Criteria: * Impaired liver function * Gastrointestinal disease that could limit drug absorption

Locations (15)

Pfizer Investigational Site

Antwerp, Belgium

Pfizer Investigational Site

Brasschaat, Belgium

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL

Time frame: Week 52

Secondary Outcomes

Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly

Time frame: Week 52

LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels

Time frame: Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study

Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study

Time frame: Baseline and Weeks 17, 34, and 52

Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study

Time frame: Week 52

Adverse events and laboratory test changes

Time frame: Weeks 17, 34, and 52

Achievement of LDL-C target

Time frame: Weeks 17 and 34

Achievement of LDL-C target by diabetic patients

Time frame: Week 52

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.