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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01587235
Other study ID # 0653A-406
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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