NCT03214211

Unknown

Prospective Observational Study of Pravafenix Cap

Yooyoung Pharmaceutical Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

YYPCT_APOLLO_OS

Study Type

observational

Estimated enrollment

3,088

Locations

1 country

Sites

1

Timeline

Study Start

August 30, 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 3,088 participants
Study completion date: June 30, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 21, 2017
Actual (reported)
First Posted
July 11, 2017
Actual (reported)
Study Start
August 30, 2017
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: August 31, 2017
Status Verified: July 2017
Last Update Submitted: August 30, 2017

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

Variation of the diabetic index (Before/after the administration of the Pravafenix Cap)
For 3 years
Variation of lipid parameter(Before/after the administration of the Pravafenix Cap)
For 3 years
Variation of inflammatory index(Before/after the administration of the Pravafenix Cap)
For 3 years
Occurrence of the major clinical events
For 3 years

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients who have dyslipidemia, already administrated or need to administrate the Pravafenix Cap.

You may qualify if:

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

Sponsors & Collaborators

Yooyoung Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Chonnam national university hospital

Gwangju, South Korea

Myung-Ho Jeong, Ph.DCONTACTmyungho@chollian.net

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

Myung-Ho Jeong, Ph.D
Chonnam National University Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Kyung Kwon, Manager

CONTACT

82-2-6202-7104 mkkwon@yypharm.co.kr

Seul-Gi Ha, Ass. Manager

CONTACT

82-2-6202-7105

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

July 11, 2017

Study Start

August 30, 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 30, 2022

Estimated (date passed)

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Not ApplicableCompleted

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

mg/dL ≤ LDL-C ≤ 160mg/dL

mg/dL ≤ TG ≤ 500mg/dL or HDL-C \< 40mg/dL(Men), 50mg/dL(Women)

Voluntary written informed consent to study participation

You may not qualify if:

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
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.

Contact the study team to confirm eligibility.

sgha@yypharm.co.kr

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

August 31, 2017

Record last verified: 2017-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT03214211
Data provider: ClinicalTrials.gov
Source updated: 2017-08-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:21 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations