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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489331
• Other study ID #: FESI5001
• Status: Completed
• Start date: July 2015
• Est. completion date: November 10, 2020

Study information

• Verified date: November 2020
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

1. 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

2. Unexpected adverse event/adverse drug reaction profile

3. Known adverse drug reaction profile

4. Non-serious adverse drug reaction profile

5. Other information related to the product safety

6. Efficacy evaluation

7. 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.

8. Study of special patient Analysis of specific patients such as elderly patients (65 years and above), patients with renal/hepatic disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Locations

Country	Name	City	State
Korea, Republic of	Daesung Medical Center	Bucheon
Korea, Republic of	DongRae BongSeng Hospital	Busan
Korea, Republic of	Isam Clinic	Busan
Korea, Republic of	Hyundai Medical Clinic	Daegu
Korea, Republic of	SANGIN Clinic of Internal Medicine	Daegu
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Namyangju Hanyang General Hospital	Gyeonggi-do
Korea, Republic of	Kim Young Ho Internal Medicine Clinic	Gyeongsang
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	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	24 weeks