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)

• ClinicalTrials.gov Identifier: NCT00535405
• Recruitment Status: Completed
• First Posted: September 26, 2007
• Results First Posted: May 25, 2010
• Last Update Posted: February 14, 2022
• Sponsor: Organon and Co
• Collaborator: Merck Shering-Plough JV Study
• Information provided by (Responsible Party): Organon and Co

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	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	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1289 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: November 2007
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :

1. Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 weeks ]
2. 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 [ Time Frame: 12 Weeks ]
   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.
3. Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 [ Time Frame: 12 Weeks ]
4. Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 Weeks ]
   Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.
5. Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 [ Time Frame: 12 Weeks ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Organon and Co

Merck Shering-Plough JV Study

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00535405
• Other Study ID Numbers: 0653A-128; 2007_588
• First Posted: September 26, 2007
• Results First Posted: May 25, 2010
• Last Update Posted: February 14, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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

Keywords provided by Organon and Co:

High Cholesterol

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atorvastatin; Simvastatin; Ezetimibe; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors