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

NCT02489331 | Completed

• 1 other identifier: FESI5001
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 10

Brief Summary

Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the "New Drug Re-examination"

Conditions

Dyslipidemias

Keywords

Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse event after Cholib administration in general medical practice

  Any adverse events occurred after Cholib® dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.

  24 weeks

• Incidence of serious adverse event after Cholib administration in general medical practice

  Any serious adverse events occurred after Cholib® dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events.

  24 weeks

Secondary Outcomes (1)

• Evaluate four categories based on Serum-Triglyceride, HDL cholesterol, LDL cholesterol, creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine level after Cholib® dosing and test date

  24 weeks

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are prescribed Cholib as per doctor's medical judgement in normal medical parctice setting

You may qualify if:

• \- 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

You may not qualify if:

• 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
• /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

Sponsors & Collaborators

• Abbott: lead

Study Sites (10)

Daesung Medical Center

Bucheon-si, 14577, South Korea

Location

Isam Clinic

Busan, 47354, South Korea

Location

DongRae BongSeng Hospital

Busan, 47889, South Korea

Location

Hyundai Medical Clinic

Daegu, 42612, South Korea

Location

SANGIN Clinic of Internal Medicine

Daegu, 42812, South Korea

Location

Konyang University Hospital

Daejeon, 35365, South Korea

Location

Namyangju Hanyang General Hospital

Gyeonggi-do, 12048, South Korea

Location

Kim Young Ho Internal Medicine Clinic

Gyeongsang, 53042, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 3, 2015
• Study Start: July 1, 2015
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

KR (10)