To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

May 8, 2024 updated by: Organon and Co

A Multicenter, Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

579

Phase

  • Phase 3

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

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg

Exclusion Criteria:

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe or atorvastatin

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Atorvastatin 80 mg
Drug: atorvastatin
Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
Drug: atorvastatin
Atorvastatin 40 mg by mouth, once a day for 6 weeks
Experimental: 2
Atorvastatin 40 mg + ezetimibe 10 mg
Drug: atorvastatin
Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
Drug: atorvastatin
Atorvastatin 40 mg by mouth, once a day for 6 weeks
Drug: ezetimibe
Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C
Time Frame: Baseline and 6 weeks
Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline and 6 weeks
Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%
Baseline and 6 weeks
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
Time Frame: Baseline and 6 Weeks
Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Total-Cholesterol
Time Frame: Baseline and 6 Weeks
Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Triglycerides (TG)
Time Frame: Baseline and 6 Weeks
Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)
Time Frame: Baseline and 6 Weeks
Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)
Time Frame: Baseline and 6 Weeks
Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio
Time Frame: Baseline and 6 Weeks
Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio
Time Frame: Baseline and 6 Weeks
Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio
Time Frame: Baseline and 6 Weeks
Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio
Time Frame: Baseline and 6 Weeks
Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Baseline and 6 Weeks
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)
Time Frame: Baseline and 6 Weeks
Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%
Baseline and 6 Weeks
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
Time Frame: 6 Weeks
6 Weeks

Collaborators and Investigators

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

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (Estimated)

January 13, 2006

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653-090
  • 2005_105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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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