Prospective Observational Study of Pravafenix Cap

• Conditions: Dyslipidemias

• Registration Number: NCT03214211
• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Brief 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 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

Not available

Study Timeline

• Study First Submitted: 2017-06-21
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Study Start: 2017-08-30
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3088

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence and mortaity about the cardiovascular disease case for 3 years from administrating the Pravafenix Cap.	For 3 years	(Occurence of the MACE for 3 years after aministrating the Pravfenix Cap)

Secondary Outcome Measures

Name	Time	Method
Variation of the diabetic index (Before/after the administration of the Pravafenix Cap)	For 3 years	FBS, HbA1c
Variation of lipid parameter(Before/after the administration of the Pravafenix Cap)	For 3 years	TC, LDL-C, TG, HDL-C
Variation of inflammatory index(Before/after the administration of the Pravafenix Cap)	For 3 years	hs-CRP
Occurrence of the major clinical events	For 3 years	eventsBefore/after the administration of the Pravafenix Cap.

Trial Locations

Locations (1)

Chonnam national university hospital; 🇰🇷 Gwangju, Korea, Republic of