Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-29 @ 7:55 PM
Study NCT ID:
NCT04714151
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2021-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Confirmatory Study of K-877 Extended Release Tablet
Sponsor:
Kowa Company, Ltd.
Organization:
Study Overview
Official Title:
A Phase III Confirmatory Study of K-877 Extended Release Tablet-A Multicenter, Active Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Dyslipidemia With High TG-
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
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 investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.
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?: