Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343298
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-20
Brief Title:
To Evaluate the Safety and Efficacy of MANP in Subjects with Difficult to Control Resistant Hypertension
Sponsor:
E-Star BioTech LLC
Organization:
E-Star BioTech LLC
Study Overview
Official Title:
A PHASE 2 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED DOSE TITRATION MULTI-CENTER STUDY to EVALUATE the SAFETY and EFFICACY of SUBCUTANEOUS MANP WHEN ADMINISTERED ONCE DAILY for 42 DAYS in PARTICIPANTS with DIFFICULT to CONTROL HYPERTENSIONRESISTANT HYPERTENSION
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
BOLD-HTN
Brief Summary:
This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure SBP derived from 24-hour ambulatory blood pressure monitoring ABPM in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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