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)

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.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01587235

Acronym

VYCTORY

Enrollment

Registered

2012-04-30

Start date

2013-03-31

Completion date

2014-05-31

Last updated

2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Brief summary

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.

Interventions

DRUGEzetimibe/simvastatin

Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.

DRUGOther Statin

Participants are prescribed a statin (any other than Vytorin) as per routine standard of care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame
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 LDL-C level 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
Change in Serum Triglycerides (TG) From Baseline	Baseline and Week 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026