DyslipidemiaMOBSNCT01414192
A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)
An observational study of Dyslipidemia and Hypercholesterolemia, run by Organon and Co.
Trial summary
This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Hypercholesterolemia
- Type of treatment
- Pill or oral medicine
- How many people
- 3,215 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2008to 15 Sep 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.
Who may be able to join
- Resident of Continental France
- Treated by ezetimibe either as monotherapy (Ezetrol®), or co-administered with a statin or administered in a fixed combination of ezetimibe and simvastatin (Inegy®)
- Incident treatment with ezetimibe at the time of recruitment into the study
Who cannot join
- Unlikely to be followed-up for the next 6 months after recruitment due to a planned change of residence
- Participating in a clinical trial
- Unable to read the information letter in French and/or unable to participate in the telephone interview in French
About this study
Official title: Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®
This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.
- Conditions
- Dyslipidemia, Hypercholesterolemia
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe monotherapy without prior treatment | Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | |
| Ezetimibe monotherpay with prior treatment | Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | |
| Ezetimibe plus statin | Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin. | |
| Ezetimibe/simvastatin | Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cardiovascular (CV) Events
Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.
Measured: up to 48 months
Secondary outcomes (5)
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months
LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.
Measured: Baseline and Month 12
Percentage of Participants With CV Risk Factors
Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol \& substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.
Measured: At enrollment (baseline)
Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months
Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.
Measured: up to 48 months
Percentage of Participants With at Least 1 Discontinuation of Study Drug
The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.
Measured: up to 48 months
Mortality Rate
The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study start15 Nov 2008
- Primary completion15 Sep 2014
- Study completion15 Sep 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414192
- Sponsor's protocol ID
- 0653A-204
- Acronym
- MOBS
- Status last verified
- Feb 2022
- First submitted
- 9 Aug 2011
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ferrieres J, Dallongeville J, Rossignol M, Benichou J, Caro JJ, Getsios D, Hernandez L, Abenhaim L, Grimaldi-Bensouda L. Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population-based study. J Clin Lipidol. 2016 Nov-Dec;10(6):1379-1388. doi: 10.1016/j.jacl.2016.08.015. Epub 2016 Sep 7.
PubMed 27919355
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®
- ClinicalTrials.gov ID
- NCT01414192
- Acronym / sponsor ID
- MOBS / 0653A-204
- Conditions
- Dyslipidemia, Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,215 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2008 (actual)
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 15 Sep 2014 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Posted 8 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe monotherapy without prior treatment | – | –Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). |
| Ezetimibe monotherpay with prior treatment | – | –Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). |
| Ezetimibe plus statin | – | –Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin. |
| Ezetimibe/simvastatin | – | –Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.
Key inclusion criteria (3 listed)
- Resident of Continental France
- Treated by ezetimibe either as monotherapy (Ezetrol®), or co-administered with a statin or administered in a fixed combination of ezetimibe and simvastatin (Inegy®)
- Incident treatment with ezetimibe at the time of recruitment into the study
Key exclusion criteria (3 listed)
- Unlikely to be followed-up for the next 6 months after recruitment due to a planned change of residence
- Participating in a clinical trial
- Unable to read the information letter in French and/or unable to participate in the telephone interview in French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Cardiovascular (CV) Events
Time frame: up to 48 months
Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.
5 secondary outcomes
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months
Time frame: Baseline and Month 12
Percentage of Participants With CV Risk Factors
Time frame: At enrollment (baseline)
Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months
Time frame: up to 48 months
Percentage of Participants With at Least 1 Discontinuation of Study Drug
Time frame: up to 48 months
Mortality Rate
Time frame: up to 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27919355Ferrieres J, Dallongeville J, Rossignol M, Benichou J, Caro JJ, Getsios D, Hernandez L, Abenhaim L, Grimaldi-Bensouda L. Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population-based study. J Clin Lipidol. 2016 Nov-Dec;10(6):1379-1388. doi: 10.1016/j.jacl.2016.08.015. Epub 2016 Sep 7.
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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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia and 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 3 inclusion and 3 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 5 Sep 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2016). 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?
Rate of Cardiovascular (CV) Events (time frame: up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414192, which also lists 1 linked publication.
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 5 Sep 2024.