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

NCT ID: NCT02069717

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Not applicable-observational study

Not applicable-observational study

Not applicable-observational study

Intervention Type OTHER

Interventions

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Not applicable-observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chonnam national university hospital

Gwangju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_FAMI_001

Identifier Type: -

Identifier Source: org_study_id