Clinical trial NCT02489331: Post Marketing Surveillance of Safety and Efficacy for Cholib in Korean Patients Under the "New Drug Re-examination".
Official title: Post Marketing Surveillance of Safety and Efficacy for Cholib® in Korean Patients Under the "New Drug Re-examination".
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemias
Keywords: Dyslipidemias
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2015-07-03
Enrollment: 193
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are prescribed Cholib as per doctor's medical judgement in normal medical parctice setting

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

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
* 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

Primary outcomes:
measure: Incidence of adverse event after Cholib administration in general medical practice
timeFrame: 24 weeks
measure: Incidence of serious adverse event after Cholib administration in general medical practice
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Daesung Medical Center
city: Busan
country: Korea, Republic of
facility: Isam Clinic
city: Busan
country: Korea, Republic of
facility: DongRae BongSeng Hospital
city: Daegu
country: Korea, Republic of
facility: Hyundai Medical Clinic
city: Daegu
country: Korea, Republic of
facility: SANGIN Clinic of Internal Medicine
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Namyangju Hanyang General Hospital
city: Gyeongsang
country: Korea, Republic of
facility: Kim Young Ho Internal Medicine Clinic
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References: