Cardiovascular DisorderPhase 4NCT00652717
Study To Assess The Efficacy Of A Cholesterol Lowering Drug On Top Of Statins In Patients After Myocardial Infarction (MI)(0653A-150)
A Phase 4 study testing Ezetimibe and simvastatin in people with Cardiovascular Disorder, run by Organon and Co.
Trial summary
Collecting local data, safety and experience trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disorder
- What is being tested?
- Ezetimibe and simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2005to 4 Aug 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients; Post Acute Coronary Syndrome
Who cannot join
- -
About this study
Official title: A Multicenter, Open Study To Evaluate The Efficacy Of Ezetimibe 10 Mg Added On Statin Therapy, In Reducing LDL Cholesterol To Target Levels In Patients After Acute Coronary Syndrome
Collecting local data, safety and experience trial.
- Conditions
- Cardiovascular Disorder
- Being tested
- Ezetimibe, simvastatin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Also called Ezetrol®, Zetia®, MK0653
Ezetimibe 10 mg daily for 42 days.
simvastatinDrug
Also called Zocor®, MK0733
simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | arm 1 - Ezetimibe 10 mg daily that was added on Statin Therapy (prescribed clinically suitable dose by the physician). Receives: Drug: Ezetimibe; Drug: simvastatin |
| 2 | Active comparator | arm 2- simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days. Receives: Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL levels
Measured: 42 Days
Secondary outcomes (2)
Safety measures
Measured: 42 days
Total cholesterol levels.
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study start1 Feb 2005
- Primary completion15 Feb 2005
- Study completion4 Aug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DisorderStudies 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
- 280 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
- NCT00652717
- Sponsor's protocol ID
- 0653A-150
- Other IDs
- 2008_009
- Status last verified
- Feb 2022
- First submitted
- 1 Apr 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Study To Evaluate The Efficacy Of Ezetimibe 10 Mg Added On Statin Therapy, In Reducing LDL Cholesterol To Target Levels In Patients After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00652717
- Acronym / sponsor ID
- 0653A-150
- Conditions
- Cardiovascular Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2005 (actual)
- Primary completion
- 15 Feb 2005 (actual)
- Study completion
- 4 Aug 2005 (actual)
- First posted
- 4 Apr 2008 (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.
Collecting local data, safety and experience trial.
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: Ezetimibe, Drug: simvastatinarm 1 - Ezetimibe 10 mg daily that was added on Statin Therapy (prescribed clinically suitable dose by the physician). |
| 2 | Active comparator | Drug: simvastatinarm 2- simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients; Post Acute Coronary Syndrome
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| EzetimibeAlso: Ezetrol®, Zetia®, MK0653Ezetimibe 10 mg daily for 42 days. | Drug | 1 |
| simvastatinAlso: Zocor®, MK0733simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days. | Drug | 1, 2 |
Primary outcome
LDL levels
Time frame: 42 Days
2 secondary outcomes
Safety measures
Time frame: 42 days
Total cholesterol levels.
Time frame: 42 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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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 Ezetimibe and simvastatin in people with Cardiovascular Disorder, 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 1 inclusion and 1 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 15 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LDL levels (time frame: 42 Days). 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 15 Aug 2024.