DyslipidemiasNCT03214211
Prospective Observational Study of Pravafenix Cap
An observational study of Dyslipidemias, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
To observe the effiacay, safety and risk of developing diabetes, review the patients chars who had administrated or neet to administrate the Pravafenix cap for enroll period, it is an prospective observational study that only collect the collectable information follwoing the hospital visiting date from enroll point to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dyslipidemias
- How many people
- 3,088 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2017to 30 Jun 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have dyslipidemia, already administrated or need to administrate the Pravafenix Cap.
Who may be able to join
- Among the patients with artheriosclerotic cardiovascular heart failure who have been hopitalized or visited the hospital.
- Men or Women over 20 years old
- Patients who had already administrated or need to administrate the Pravafenix Cap
- Patients who have abnormal opinion(dyslipidemia) about LDL-C, TG, HDL-C at the enroll point
- 70mg/dL ≤ LDL-C ≤ 160mg/dL
- 150mg/dL ≤ TG ≤ 500mg/dL or HDL-C < 40mg/dL(Men), 50mg/dL(Women)
- Voluntary written informed consent to study participation
Who cannot join
- Patient who have hypersensitivity about Pravafenix Cap or ingredients of the Pravafenix Cap.
- Patients suffer from liver disease (Biliary cirrhosis, activated hepatophay or lasting potentiation of the transaminase 3 times excess from normal valus(which has no cause).
- Patients suffer from kidney disease(CCR < 60ml/min)
- Patients have photo-allergy (allergic reaction causeed by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates(lipid-modifying medicines) or ketoprofen (an anti-inflammatory medicine that can be used orally or on the skin for muscle and bone disorders, and orally for gout or period pain).
- Acute or chronic patients who have high triglycerides academia.
- Pregnant or breat-feeding
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- Someone who have a history of muscle problems during treatment with cholesterol-controlling medicines called 'statins' (such as simvastatin, atorvastatin, pravastatin or rosuvastatin) or fibrates (such as fenofibrate and bezafibrate).
- Pateints who have uncontrolled hypothyroidism or hyperthyroidism.
- Patinets who couldn't be participated in the study by the other opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam national university hospital
Gwangju
Myung-Ho Jeong, Ph.D, myungho@chollian.net
About this study
Official title: Assess the Long-term Safety and Efficacy of Pravafenix Cap. in Korean Patients With Dyslipidemia: a Multicenter, Prospective, Observational Study
To observe the effiacay, safety and risk of developing diabetes, review the patients chars who had administrated or neet to administrate the Pravafenix cap for enroll period, it is an prospective observational study that only collect the collectable information follwoing the hospital visiting date from enroll point to information collecting date. There is no extra visit for this study.
Observe the data which has been collected for 3 yearts every year from enroll point, if the patients agree to be participated in this study and are suitable in inclusion/exclusion criteria.
If the lipid-lowering drugs(only Ezetimibe is possible) is add-on the Pravafenix Cap administrating period, it will be analyzed by laering analysis separately. But, the reason why it is add-on to have to be written on e-CRF.
- Conditions
- Dyslipidemias
- Medical subject headings
- Dyslipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and mortaity about the cardiovascular disease case for 3 years from administrating the Pravafenix Cap.
(Occurence of the MACE for 3 years after aministrating the Pravfenix Cap)
Measured: For 3 years
Secondary outcomes (4)
Variation of the diabetic index (Before/after the administration of the Pravafenix Cap)
FBS, HbA1c
Measured: For 3 years
Variation of lipid parameter(Before/after the administration of the Pravafenix Cap)
TC, LDL-C, TG, HDL-C
Measured: For 3 years
Variation of inflammatory index(Before/after the administration of the Pravafenix Cap)
hs-CRP
Measured: For 3 years
Occurrence of the major clinical events
eventsBefore/after the administration of the Pravafenix Cap.
Measured: For 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start30 Aug 2017 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,088 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung-Ho Jeong, Ph.D, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214211
- Sponsor's protocol ID
- YYPCT_APOLLO_OS
- Status last verified
- Jul 2017
- First submitted
- 21 Jun 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Long-term Safety and Efficacy of Pravafenix Cap. in Korean Patients With Dyslipidemia: a Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03214211
- Acronym / sponsor ID
- YYPCT_APOLLO_OS
- Conditions
- Dyslipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,088 participants (estimated)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2017 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Jul 2017 (actual)
- 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.
To observe the effiacay, safety and risk of developing diabetes, review the patients chars who had administrated or neet to administrate the Pravafenix cap for enroll period, it is an prospective observational study that only collect the collectable information follwoing the hospital visiting date from enroll point to information collecting date. There is no extra visit for this study.
Observe the data which has been collected for 3 yearts every year from enroll point, if the patients agree to be participated in this study and are suitable in inclusion/exclusion criteria.
If the lipid-lowering drugs(only Ezetimibe is possible) is add-on the Pravafenix Cap administrating period, it will be analyzed by laering analysis separately. But, the reason why it is add-on to have to be written on e-CRF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have dyslipidemia, already administrated or need to administrate the Pravafenix Cap.
Key inclusion criteria (7 listed)
- Among the patients with artheriosclerotic cardiovascular heart failure who have been hopitalized or visited the hospital.
- Men or Women over 20 years old
- Patients who had already administrated or need to administrate the Pravafenix Cap
- Patients who have abnormal opinion(dyslipidemia) about LDL-C, TG, HDL-C at the enroll point
- Voluntary written informed consent to study participation
Key exclusion criteria (9 listed)
- Patient who have hypersensitivity about Pravafenix Cap or ingredients of the Pravafenix Cap.
- Patients suffer from liver disease (Biliary cirrhosis, activated hepatophay or lasting potentiation of the transaminase 3 times excess from normal valus(which has no cause).
- Patients suffer from kidney disease(CCR < 60ml/min)
- Patients have photo-allergy (allergic reaction causeed by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates(lipid-modifying medicines) or ketoprofen (an anti-inflammatory medicine that can be used orally or on the skin for muscle and bone disorders, and orally for gout or period pain).
- Acute or chronic patients who have high triglycerides academia.
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
Occurrence and mortaity about the cardiovascular disease case for 3 years from administrating the Pravafenix Cap.
Time frame: For 3 years
(Occurence of the MACE for 3 years after aministrating the Pravfenix Cap)
4 secondary outcomes
Variation of the diabetic index (Before/after the administration of the Pravafenix Cap)
Time frame: For 3 years
Variation of lipid parameter(Before/after the administration of the Pravafenix Cap)
Time frame: For 3 years
Variation of inflammatory index(Before/after the administration of the Pravafenix Cap)
Time frame: For 3 years
Occurrence of the major clinical events
Time frame: For 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
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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.
Myung-Ho Jeong, Ph.D principal investigator
Chonnam National University Hospital
1 site 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 Yooyoung Pharmaceutical Co., Ltd. at 1 site 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Kyung Kwon, Manager (82-2-6202-7104, mkkwon@yypharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence and mortaity about the cardiovascular disease case for 3 years from administrating the Pravafenix Cap. (time frame: For 3 years). 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 31 Aug 2017.