HypercholesterolemiaPhase 3NCT00496730
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
A Phase 3 study testing simvastatin (+) ezetimibe and Comparator: atorvastatin in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- simvastatin (+) ezetimibe and Comparator: atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement
- No history of diabetes and 100 <=LDL-C <=250 mg/dl
Who cannot join
- Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months
- Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
- Uncontrolled hypertension
- Unstable angina
About this study
Official title: A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea
Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.
- Conditions
- Hypercholesterolemia
- Being tested
- simvastatin (+) ezetimibe, Comparator: atorvastatin
- Keywords
- Metabolic Disorder
- Medical subject headings
- Hypercholesterolemia, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatin (+) ezetimibeDrug
Also called MK0653A, Vytorin®
simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
Comparator: atorvastatinDrug
Also called Lipitor®
atorvastatin 10 mg; tablet, once daily, 8 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Vytorin® | Experimental | simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks Receives: Drug: simvastatin (+) ezetimibe |
| atorvastatin | Active comparator | atorvastatin 10 mg; tablet, once daily, 8 Weeks Receives: Drug: Comparator: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
Measured: Baseline and 8 Weeks
Secondary outcomes (1)
Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496730
- Sponsor's protocol ID
- 0653A-129
- Other IDs
- MK0653A-129, 2007_017
- Status last verified
- Feb 2022
- First submitted
- 2 Jul 2007
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea
- ClinicalTrials.gov ID
- NCT00496730
- Acronym / sponsor ID
- 0653A-129
- Conditions
- Hypercholesterolemia
- Keywords
- Metabolic Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Posted 17 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.
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: simvastatin (+) ezetimibesimvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks |
| atorvastatin | Active comparator | Drug: Comparator: atorvastatinatorvastatin 10 mg; tablet, once daily, 8 Weeks |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement
- No history of diabetes and 100 <=LDL-C <=250 mg/dl
Key exclusion criteria (5 listed)
- Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months
- Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
- Uncontrolled hypertension
- Unstable angina
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 |
|---|---|---|
| simvastatin (+) ezetimibeAlso: MK0653A, Vytorin®simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks | Drug | Vytorin® |
| Comparator: atorvastatinAlso: Lipitor®atorvastatin 10 mg; tablet, once daily, 8 Weeks | Drug | atorvastatin |
Primary outcome
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
Time frame: Baseline and 8 Weeks
1 secondary outcome
Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
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Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing simvastatin (+) ezetimibe and Comparator: atorvastatin in people with Hypercholesterolemia, 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 5 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: finished, as of the sponsor's last update on 16 May 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. (time frame: Baseline and 8 Weeks). 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 16 May 2024.