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Prospective Observational Study of Pravafenix Cap

NCT ID: NCT03214211

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3088 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-30

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Among the patients with artheriosclerotic cardiovascular heart failure who have been hopitalized or visited the hospital.

1. Men or Women over 20 years old
2. Patients who had already administrated or need to administrate the Pravafenix Cap
3. 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)
4. Voluntary written informed consent to study participation

Exclusion Criteria

1. Patient who have hypersensitivity about Pravafenix Cap or ingredients of the Pravafenix Cap.
2. 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).
3. Patients suffer from kidney disease(CCR \< 60ml/min)
4. 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).
5. Acute or chronic patients who have high triglycerides academia.
6. Pregnant or breat-feeding
7. 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).
8. Pateints who have uncontrolled hypothyroidism or hyperthyroidism.
9. Patinets who couldn't be participated in the study by the other opinion of the investigator.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yooyoung Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myung-Ho Jeong, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Locations

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Chonnam national university hospital

Gwangju, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Min-Kyung Kwon, Manager

Role: CONTACT

Phone: 82-2-6202-7104

Email: [email protected]

Seul-Gi Ha, Ass. Manager

Role: CONTACT

Phone: 82-2-6202-7105

Email: [email protected]

Facility Contacts

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Myung-Ho Jeong, Ph.D

Role: primary

Other Identifiers

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YYPCT_APOLLO_OS

Identifier Type: -

Identifier Source: org_study_id