DyslipidemiaPhase 4VYCTORYNCT01587235
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)
A Phase 4 study testing Ezetimibe/simvastatin and Other Statin in people with Dyslipidemia, run by Organon and Co.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Ezetimibe/simvastatin and Other Statin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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.
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.
- Conditions
- Dyslipidemia
- Being tested
- Ezetimibe/simvastatin, Other Statin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe/simvastatinDrug
Also called Vytorin
Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
Other StatinDrug
Participants are prescribed a statin (any other than Vytorin) as per routine standard of care
| Study group | Role | What they receive |
|---|---|---|
| Vytorin | Experimental | Not described Receives: Drug: Ezetimibe/simvastatin |
| Other Statin | Active comparator | Not described Receives: Drug: Other Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 6
Secondary outcomes (10)
Change in LDL-C level From Baseline
Measured: Baseline and Week 6
Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL
Measured: Week 6
Change in Serum LDL From Baseline
Measured: Baseline and Week 6
Change in Total Cholesterol From Baseline
Measured: Baseline and Week 6
Change in High-density lipoprotein (HDL) From Baseline
Measured: Baseline and Week 6
Change in Serum Triglycerides (TG) From Baseline
Measured: Baseline and Week 6
Change in Serum Non-HDL From Baseline
Measured: Baseline and Week 6
Change in LDL-C/HDL-C Ratio From Baseline
Measured: Baseline and Week 6
Change in Apolipoprotein B (ApoB) From Baseline
Measured: 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))
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587235
- Sponsor's protocol ID
- 0653A-406
- Acronym
- VYCTORY
- Status last verified
- Feb 2022
- First submitted
- 26 Apr 2012
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01587235
- Acronym / sponsor ID
- VYCTORY / 0653A-406
- Conditions
- Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vytorin | Experimental | Drug: Ezetimibe/simvastatin |
| Other Statin | Active comparator | Drug: Other Statin |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ezetimibe/simvastatinAlso: VytorinAlgorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily. | Drug | Vytorin |
| Other StatinParticipants are prescribed a statin (any other than Vytorin) as per routine standard of care | Drug | Other Statin |
Primary outcome
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
10 secondary outcomes
Change in LDL-C level From Baseline
Time frame: Baseline and Week 6
Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL
Time frame: Week 6
Change in Serum LDL From Baseline
Time frame: Baseline and Week 6
Change in Total Cholesterol From Baseline
Time frame: Baseline and Week 6
Change in High-density lipoprotein (HDL) From Baseline
Time frame: Baseline and Week 6
Change in Serum Triglycerides (TG) From Baseline
Time frame: Baseline and Week 6
Change in Serum Non-HDL From Baseline
Time frame: Baseline and Week 6
Change in LDL-C/HDL-C Ratio From Baseline
Time frame: Baseline and Week 6
Change in Apolipoprotein B (ApoB) From Baseline
Time frame: 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))
Time frame: Week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ezetimibe/simvastatin and Other Statin in people with Dyslipidemia, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.