A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Atorvastatin 10 mg; Drug: Ezetimibe 10 mg/simvastatin 20 mg; Drug: Atorvastatin 20 mg; Drug: Ezetimibe 10 mg/simvastatin 40 mg; Drug: Atorvastatin 40 mg

• Study Type: Interventional
• Enrollment (Actual): 1289
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient has a cholesterol level of 130 mg/dL or greater
• Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
• Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Exclusion Criteria:

• Patient weighs less than 100 lbs
• Patient has an allergy to ezetimibe, simvastatin or atorvastatin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Each patient will receive 1 active treatment dose & 2 Placebo (Pbo) doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Atorvastatin 10 mg; Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
Experimental: 2; Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Ezetimibe 10 mg/simvastatin 20 mg; Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
Experimental: 3; Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Atorvastatin 20 mg; Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
Experimental: 4; Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Ezetimibe 10 mg/simvastatin 40 mg; Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
Experimental: 5; Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.	Drug: Atorvastatin 40 mg; Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12		12 weeks
Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12	Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.	12 Weeks
Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12		12 Weeks
Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12	Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.	12 Weeks
Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12	Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.	12 Weeks

Collaborators and Investigators

• Sponsor: Organon and Co
• Collaborators: Merck Shering-Plough JV Study
• Investigators: Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 25, 2007
• First Submitted That Met QC Criteria: September 25, 2007
• First Posted (Estimated): September 26, 2007

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: High Cholesterol
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Simvastatin; Ezetimibe
• Other Study ID Numbers: 0653A-128; 2007_588

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