Metabolic SyndromeNCT02069717
Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule)
An observational study of Metabolic Syndrome, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Not applicable-observational study
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Sep 2014
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged more than 20 with history of acute myocardial infarction and diagnosed with metabolic syndrome
Who may be able to join
- patients >20 years of age.
- history of acute myocardial infarction
- metabolic syndrome diagnosis
Who cannot join
- current liver disease or AST or ALT greater than 3 times the upper limit of reference range
- pre-existing gallbladder disease
- moderate to severe renal disorder (serum creatinine >2.5mg/dL)
- pancreatitis diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Prospective, Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule) Add-on to Statin Therapy in Patients Who Have History of Acute Myocardial Infarction and Are Diagnosed With Metabolic Syndrome
The purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Not applicable-observational study
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable-observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| Not applicable-observational study | Not applicable-observational study Receives: Other: Not applicable-observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of the major adverse cardiovascular events (MACE)
cardiac death, MI, re-PCI, CABG
Measured: 24 months
Secondary outcomes (1)
The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE)
non-cardiac death, stroke, hospitalization for acute coronary syndrome
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069717
- Sponsor's protocol ID
- DW_FAMI_001
- Status last verified
- Oct 2016
- First submitted
- 18 Feb 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule) Add-on to Statin Therapy in Patients Who Have History of Acute Myocardial Infarction and Are Diagnosed With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02069717
- Acronym / sponsor ID
- DW_FAMI_001
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Feb 2014 (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.
The purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not applicable-observational study | – | Other: Not applicable-observational studyNot applicable-observational study |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged more than 20 with history of acute myocardial infarction and diagnosed with metabolic syndrome
Key inclusion criteria (3 listed)
- patients >20 years of age.
- history of acute myocardial infarction
- metabolic syndrome diagnosis
Key exclusion criteria (4 listed)
- current liver disease or AST or ALT greater than 3 times the upper limit of reference range
- pre-existing gallbladder disease
- moderate to severe renal disorder (serum creatinine >2.5mg/dL)
- pancreatitis diagnosis
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 |
|---|---|---|
| Not applicable-observational study | Other | Not applicable-observational study |
Primary outcome
The incidence rate of the major adverse cardiovascular events (MACE)
Time frame: 24 months
cardiac death, MI, re-PCI, CABG
1 secondary outcome
The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE)
Time frame: 24 months
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 26 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 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: withdrawn, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
The incidence rate of the major adverse cardiovascular events (MACE) (time frame: 24 months). 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 26 Oct 2016.