Last updated on December 2018

Post Marketing Surveillance of Safety and Efficacy for Cholib in Korean Patients Under the "New Drug Re-examination".

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dyslipidemia
  • Age: Between 19 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Clinical diagnosis of mixed dyslipidaemia who has high triglycerides and low HDL cholesterol level while LDL cholesterol levels are adequately controlled with the corresponding dose of simvastatin monotherapy

Exclusion Criteria:

  • Patients who are hypersensitive (allergic) to peanuts, soybean or any of the ingredients of the medicine
  • Patients who experienced photoallergy or phototoxic reactions during treatment with fibrates or ketoprofen
  • Patients who have active hepatic disorder or have serum transaminase increased continuously without identified reason
  • Patients who have gallbladder disease
  • Patients who have chronic or acute pancreatitis except acute pancreatitis due to severe hypertriglyceridemia
  • Patients who have moderately or severely reduced kidney function(estimated glomerular filtration rate < 60mL/min/1.73m2)
  • Cholib administration combined administration with fibrates, statins, danazol, cyclosporine or strong cytochrome P450(CYP)3A4 inhibitor
  • 145/40mg Cholib Combined administration with amiodarone, verapamil, amlodipine or diltiazem
  • Children <19 years
  • Pregnant or breast-feeding women
  • Patients with biliary cirrhosis
  • Patients who have myopathy and/or previously had rhabdomyolysis or myopathy while taking statins and/or fibrates or had 5 times more creatine phosphokinase than Upper limit of Normal (ULN) while taking statins previously
  • Patients who have rare hereditary problems with lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption since this drug contains lactose
  • Patients who have rare hereditary problems with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency since this drug contains sucrose
  • Patients who have LDL Cholesterol 130 mg/dL and triglyceride < 150mg/dL and HDL cholesterol 60mg/dL Investigators will refer to the product market authorization (label) for inclusion/exclusion criteria

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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