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)

Phase 4

Withdrawn

• Conditions: Dyslipidemia
• Interventions: Drug: Ezetimibe/simvastatin; Drug: Other Statin

• Registration Number: NCT01587235
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Study Start: 2013-03
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vytorin	Ezetimibe/simvastatin	-
Other Statin	Other Statin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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