Post Marketing Surveillance of Safety a… | Clinical Trial

Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Daesung Medical Center, Bucheon-si, South Korea

About this study

The objective of this surveillance is to identify problems and questions on Cholib® and on the following matters under the condition that the investigational product is in use.

Serious adverse event and adverse drug reaction profile

Death or a life-threatening condition
Hospitalization or prolonged hospitalization
Persistent or significant disability/incapacity
Congenital anomaly/birth defect
Other medically significant events
Unexpected adverse event/adverse drug reaction profile
Known adverse drug reaction profile
Non-serious adverse drug reaction profile
Other information related to the product safety
Efficacy evaluation
Study of extended follow-up Surveillance of the safety and efficacy of the subjects who received Cholib® for long-term use at least 24 weeks.
Study of special patient Analysis of specific patients such as elderly patients (65 years and above), patients with renal/hepatic disease

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of adverse event after Cholib administration in general medical practice

Time frame: 24 weeks

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

Time frame: 24 weeks

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.

Secondary outcomes

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

Time frame: 24 weeks

All subjects who received Cholib® for at least 12 weeks and follow-up at 24 weeks will be evaluated for efficacy using the four-criteria as follows:

Improved, unchanged, exacerbated, not assessable

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Jul 3, 2015
Registry last updated: Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed