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Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule)

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ClinicalTrials.gov Identifier: NCT02069717
Recruitment Status : Withdrawn
First Posted : February 24, 2014
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Metabolic Syndrome Other: Not applicable-observational study

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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
Study Start Date : October 2013
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Not applicable-observational study
Not applicable-observational study
Other: Not applicable-observational study


Outcome Measures

Primary Outcome Measures :
  1. The incidence rate of the major adverse cardiovascular events (MACE) [ Time Frame: 24 months ]
    cardiac death, MI, re-PCI, CABG


Secondary Outcome Measures :
  1. The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE) [ Time Frame: 24 months ]
    non-cardiac death, stroke, hospitalization for acute coronary syndrome


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects aged more than 20 with history of acute myocardial infarction and diagnosed with metabolic syndrome
Criteria

Inclusion Criteria:

  • patients >20 years of age.
  • history of acute myocardial infarction
  • metabolic syndrome diagnosis

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069717


Locations
Korea, Republic of
Chonnam national university hospital
Gwangju, Korea, Republic of, 501-757
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
More Information

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02069717     History of Changes
Other Study ID Numbers: DW_FAMI_001
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents