HypercholesterolemiaPhase 4NCT00442897
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
A Phase 4 study testing simvastatin (+) ezetimibe and Comparator: atorvastatin in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 229 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2008
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are naïve to lowering lipid agent
- Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.
Who cannot join
- Impaired kidney function
- Increased liver enzyme levels
- Pregnant women
- Hypersensitivity to ezetimibe and other statin agents
About this study
Official title: Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
- Conditions
- Hypercholesterolemia
- Being tested
- simvastatin (+) ezetimibe, Comparator: atorvastatin
- Keywords
- Hypercholesterolaemia
- Medical subject headings
- Hypercholesterolemia
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 10/20mg, tablet, once daily, 12wks(sub group:24wks)
Comparator: atorvastatinDrug
Also called Lipitor®
atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: simvastatin (+) ezetimibe |
| 2 | Active comparator | Not described Receives: Drug: Comparator: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
Primary objective is to evaluate the proportion of patients achieving LDL-C target <100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)
Measured: After 6 weeks of treatment
Secondary outcomes (1)
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment
If patients didn't achieve LDL-C <100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.
Measured: After 12 weeks of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startSep 2006
- Primary completionOct 2008
- Study completionOct 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 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
- NCT00442897
- Sponsor's protocol ID
- 0653A-126
- Other IDs
- MK0653A-126, 2007_006
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2007
- Last updated
- 22 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00442897
- Acronym / sponsor ID
- 0653A-126
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Mar 2007 (estimated)
- Results
- Posted 9 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: simvastatin (+) ezetimibe |
| 2 | Active comparator | Drug: Comparator: atorvastatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are naïve to lowering lipid agent
- Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.
Key exclusion criteria (4 listed)
- Impaired kidney function
- Increased liver enzyme levels
- Pregnant women
- Hypersensitivity to ezetimibe and other statin agents
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 10/20mg, tablet, once daily, 12wks(sub group:24wks) | Drug | 1 |
| Comparator: atorvastatinAlso: Lipitor®atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks) | Drug | 2 |
Primary outcome
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
Time frame: After 6 weeks of treatment
Primary objective is to evaluate the proportion of patients achieving LDL-C target <100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)
1 secondary outcome
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment
Time frame: After 12 weeks of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 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 4 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 22 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 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?
Yes. Results are posted in the registry (first posted 9 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?
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment (time frame: After 6 weeks of treatment). 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 22 May 2024.