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

Daewoong Pharmaceutical

Status: Withdrawn

Conditions: Metabolic Syndrome

Treatments: Other: Not applicable-observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT02069717

DW_FAMI_001

Details and patient eligibility

About

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Not applicable-observational study

Description:

Not applicable-observational study

Treatment:

Other: Not applicable-observational study