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

NCT ID: NCT02489331

Last Updated: 2020-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 193 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2020-11-10

Brief Summary

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

Detailed 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

Conditions

Dyslipidemias

Keywords

Dyslipidemias

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Daesung Medical Center

Bucheon-si, , South Korea

Isam Clinic

Busan, , South Korea

DongRae BongSeng Hospital

Busan, , South Korea

Hyundai Medical Clinic

Daegu, , South Korea

SANGIN Clinic of Internal Medicine

Daegu, , South Korea

Konyang University Hospital

Daejeon, , South Korea

Namyangju Hanyang General Hospital

Gyeonggi-do, , South Korea

Kim Young Ho Internal Medicine Clinic

Gyeongsang, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

FESI5001

Identifier Type: -

Identifier Source: org_study_id