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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Multicenter, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2018
        • Pfizer Investigational Site
      • Brasschaat, Belgium, 2930
        • Pfizer Investigational Site
      • Brussels, Belgium, 1180
        • Pfizer Investigational Site
      • Genk, Belgium, B-3600
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Gilly (charleroi), Belgium, 6060
        • Pfizer Investigational Site
      • La Louvière, Belgium, 7100
        • Pfizer Investigational Site
      • Mechelen, Belgium, 2800
        • Pfizer Investigational Site
      • Menen, Belgium, 8930
        • Pfizer Investigational Site
      • Merksem, Belgium, 2170
        • Pfizer Investigational Site
      • Mortsel, Belgium, 2640
        • Pfizer Investigational Site
      • Roeselare, Belgium, 8800
        • Pfizer Investigational Site
      • Seraing, Belgium, 4100
        • Pfizer Investigational Site
      • Wilrijk, Belgium, 2610
        • Pfizer Investigational Site
      • Wingene, Belgium, 8750
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Atorvastatin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly
Time Frame: Week 52
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
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
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
Week 52
Adverse events and laboratory test changes
Time Frame: Weeks 17, 34, and 52
Weeks 17, 34, and 52
Achievement of LDL-C target
Time Frame: Weeks 17 and 34
Weeks 17 and 34
Achievement of LDL-C target by diabetic patients
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2581112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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