Clinical trial NCT01587235: 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)
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Dyslipidemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Week 6
Secondary outcomes:
measure: Change in LDL-C level From Baseline
timeFrame: Baseline and Week 6
measure: Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL
timeFrame: Week 6
measure: Change in Serum LDL From Baseline
timeFrame: Baseline and Week 6
measure: Change in Total Cholesterol From Baseline
timeFrame: Baseline and Week 6
measure: Change in High-density lipoprotein (HDL) From Baseline
timeFrame: Baseline and Week 6
measure: Change in Serum Triglycerides (TG) From Baseline
timeFrame: Baseline and Week 6
measure: Change in Serum Non-HDL From Baseline
timeFrame: Baseline and Week 6
measure: Change in LDL-C/HDL-C Ratio From Baseline
timeFrame: Baseline and Week 6
measure: Change in Apolipoprotein B (ApoB) From Baseline
timeFrame: Baseline and Week 6
measure: Number of Participants who Achieve non-HDL-C goal (High-risk <100 mg/dL; Moderate-high and High risk <160 mg/dL))
timeFrame: Week 6
Other outcomes:
Locations:
Study officials:
References: