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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02069717
First Posted: February 24, 2014
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
  Purpose
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 Intervention
Metabolic Syndrome Other: Not applicable-observational study

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

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


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: October 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Not applicable-observational study
Not applicable-observational study
Other: Not applicable-observational study

  Eligibility

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 Submitted: February 18, 2014
First Posted: February 24, 2014
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