Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293417
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-19
Brief Title:
To Assess With Ezefeno Tab in Patients With Dyslipidemia and T2DM
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
Official Title:
To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy
Status:
RECRUITING
Status Verified Date:
2024-08
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:
ENSEMBLE
Brief Summary:
The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno The primary endpoint are
major adverse cardiovascular events within 48 months of the trial duration
microvascular events within 48 months of the trial duration
major adverse cardiovascular events within 48 months of the trial duration
microvascular events within 48 months of the trial duration
Detailed Description:
A prospective randomized open-label parallel multicenter active-drug-controlled clinical trial to assess the long-term efficacy and safety of Combined Therapy with Ezefeno Tab in patients with dyslipidemia who do not achieve adequate control of Non-HDL-C levels even with Moderate-intensity monotherapy
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