Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03214211
Status:
UNKNOWN
Last Update Posted:
2017-08-31
First Post:
2017-06-21
Brief Title:
Prospective Observational Study of Pravafenix Cap
Sponsor:
Yooyoung Pharmaceutical Co Ltd
Organization:
Yooyoung Pharmaceutical Co Ltd
Study Overview
Official Title:
Assess the Long-term Safety and Efficacy of Pravafenix Cap in Korean Patients With Dyslipidemia a Multicenter Prospective Observational Study
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inclusionexclusion criteria
If the lipid-lowering drugsonly 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
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 inclusionexclusion criteria
If the lipid-lowering drugsonly 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None