Prospective Observational Study of Pravafenix Cap

Dyslipidemias Clinical Trial

Official title:

Assess the Long-term Safety and Efficacy of Pravafenix Cap. in Korean Patients With Dyslipidemia: a Multicenter, Prospective, Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03214211
• Other study ID #: YYPCT_APOLLO_OS
• Status: Not yet recruiting
• Phase: N/A
• First received: June 21, 2017
• Last updated: August 30, 2017
• Start date: August 30, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2017
• Source: Yooyoung Pharmaceutical Co.,Ltd.
• Contact: Min-Kyung Kwon, Manager
• Phone: 82-2-6202-7104
• Email: mkkwon[@]yypharm.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3088
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Locations

Country	Name	City	State
Korea, Republic of	Chonnam national university hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Yooyoung Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	For 3 years
Secondary	Variation of the diabetic index (Before/after the administration of the Pravafenix Cap)	FBS, HbA1c	For 3 years
Secondary	Variation of lipid parameter(Before/after the administration of the Pravafenix Cap)	TC, LDL-C, TG, HDL-C	For 3 years
Secondary	Variation of inflammatory index(Before/after the administration of the Pravafenix Cap)	hs-CRP	For 3 years
Secondary	Occurrence of the major clinical events	eventsBefore/after the administration of the Pravafenix Cap.	For 3 years