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)

Dyslipidemia Clinical Trial

— VYCTORY  

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01587235
• Other study ID #: 0653A-406
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Ezetimibe/simvastatin
Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
• Other Statin
Participants are prescribed a statin (any other than Vytorin) as per routine standard of care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

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