A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406) (VYCTORY)

A Multicenter, Open-label, 6 Week Study to Evaluate the Efficacy and Safety of Algorithm Based Intensive Treatment With Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Patients.

This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current standard treatment with other statins for the treatment of dyslipidemia in moderate, moderately-high and high-risk participants.

Study Overview

• Status: Withdrawn
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Ezetimibe/simvastatin; Drug: Other Statin

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL
• Either treatment naïve (no previous treatment with lipid-lowering medication) or if previously treated with lipid-lowering medication, must complete a wash-out 6 weeks prior to enrollment

Exclusion Criteria:

• LDL-C level ≥ 190 mg/dL
• Hypersensitivity or intolerance to Vytorin, ezetimibe or simvastatin
• Taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc)
• Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
• Currently participating in or has previously participated in a study within 30 days
• Congestive heart failure defined by New York Heart Association (NYHA) Class III or IV within previous 6 months
• Uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ECG) changes
• Unstable angina pectoris
• Myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months
• Unstable or severe peripheral artery disease within previous 3 months
• Uncontrolled hypertension (treated or untreated)
• Type 1 or Type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months)
• Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
• Serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months
• Received treatment with systemic corticosteroids, any cyclical hormones

within previous 8 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vytorin	Drug: Ezetimibe/simvastatin; Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.; Other Names: Vytorin
Active Comparator: Other Statin	Drug: Other Statin; Participants are prescribed a statin (any other than Vytorin) as per routine standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants who Achieve Low-density Lipoprotein Cholesterol (LDL-C) goal (High-risk <100 mg/dL; Moderate-high and High risk <130 mg/dL)	Week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in LDL-C level From Baseline	Baseline and Week 6
Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL	Week 6
Change in Serum LDL From Baseline	Baseline and Week 6
Change in Total Cholesterol From Baseline	Baseline and Week 6
Change in High-density lipoprotein (HDL) From Baseline	Baseline and Week 6
Change in Serum Triglycerides (TG) From Baseline	Baseline and Week 6
Change in Serum Non-HDL From Baseline	Baseline and Week 6
Change in LDL-C/HDL-C Ratio From Baseline	Baseline and Week 6
Change in Apolipoprotein B (ApoB) From Baseline	Baseline and Week 6
Number of Participants who Achieve non-HDL-C goal (High-risk <100 mg/dL; Moderate-high and High risk <160 mg/dL))	Week 6

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
• Other Study ID Numbers: 0653A-406