DyslipidemiasNCT02489331
Post Marketing Surveillance of Safety and Efficacy for Cholib in Korean Patients Under the "New Drug Re-examination".
An observational study of Dyslipidemias, run by Abbott at 10 sites in South Korea.
Trial summary
Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the "New Drug Re-examination" Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemias
- How many people
- 193 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Jul 2015to 10 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are prescribed Cholib as per doctor's medical judgement in normal medical parctice setting
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Daesung Medical Center
Bucheon-si, 14577
Isam Clinic
Busan, 47354
DongRae BongSeng Hospital
Busan, 47889
Hyundai Medical Clinic
Daegu, 42612
SANGIN Clinic of Internal Medicine
Daegu, 42812
Konyang University Hospital
Daejeon, 35365
Namyangju Hanyang General Hospital
Gyeonggi-do, 12048
Kim Young Ho Internal Medicine Clinic
Gyeongsang, 53042
Korea University Anam Hospital
Seoul, 02841
Chung-Ang University Hospital
Seoul, 06973
About this study
Official title: Post Marketing Surveillance of Safety and Efficacy for Cholib® in Korean Patients Under the "New Drug Re-examination".
Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the "New Drug Re-examination"
Read the 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.
- 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
- Conditions
- Dyslipidemias
- Keywords
- Dyslipidemias
- Medical subject headings
- Dyslipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489331
- Sponsor's protocol ID
- FESI5001
- Status last verified
- Nov 2020
- First submitted
- 24 Jun 2015
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of Safety and Efficacy for Cholib® in Korean Patients Under the "New Drug Re-examination".
- ClinicalTrials.gov ID
- NCT02489331
- Acronym / sponsor ID
- FESI5001
- Conditions
- Dyslipidemias
- Keywords
- Dyslipidemias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are prescribed Cholib as per doctor's medical judgement in normal medical parctice setting
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by Abbott at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event after Cholib administration in general medical practice (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.