NCT03214211

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,088

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 31, 2017

Status Verified

July 1, 2017

Enrollment Period

4.8 years

First QC Date

June 21, 2017

Last Update Submit

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.
  • 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.

Sponsors & Collaborators

Study Sites (1)

Chonnam national university hospital

Gwangju, South Korea

Location

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

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

Seul-Gi Ha, Ass. Manager

CONTACT

82-2-6202-7105sgha@yypharm.co.kr

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

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 31, 2017

Record last verified: 2017-07

Locations

KR(1)