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) (VYCTORY)
This study has been withdrawn prior to enrollment.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01587235
First received: April 26, 2012
Last updated: December 2, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidemia |
Drug: Ezetimibe/simvastatin Drug: Other Statin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- 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) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in LDL-C level From Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- Change in Serum LDL From Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Change in Total Cholesterol From Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Change in High-density lipoprotein (HDL) From Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Change in Serum Triglycerides (TG) From Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Change in Serum Non-HDL From Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Change in LDL-C/HDL-C Ratio From Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Change in Apolipoprotein B (ApoB) From Baseline [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
- Number of Participants who Achieve non-HDL-C goal (High-risk <100 mg/dL; Moderate-high and High risk <160 mg/dL)) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vytorin |
Drug: Ezetimibe/simvastatin
Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
Other Name: Vytorin
|
| Active Comparator: Other Statin |
Drug: Other Statin
Participants are prescribed a statin (any other than Vytorin) as per routine standard of care
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01587235 History of Changes |
| Other Study ID Numbers: | 0653A-406 |
| Study First Received: | April 26, 2012 |
| Last Updated: | December 2, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Simvastatin Ezetimibe Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013