Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05247528
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2021-12-22
Brief Title:
Safety And Tolerability Of Subcutaneous MANP In Difficult To ControlResistant Hypertensive Subjects
Sponsor:
E-Star BioTech LLC
Organization:
E-Star BioTech LLC
Study Overview
Official Title:
A Phase 1B Multiple Ascending Dose Trial Examining The Safety And Tolerability Of Subcutaneous MANP In Difficult To ControlResistant Hypertensive Subjects
Status:
COMPLETED
Status Verified Date:
2022-11
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:
DTCRHS
Brief Summary:
A randomized double-blind placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening The study will consist of screening PK-unit admittance and safety follow up periods
Subjects will be randomized at a 62 ratio of either MANP or placebo and will be stratified by race in each dosage cohort The entire first Cohort will be given the lowest dosage with subsequent cohorts progressing sequentially to the higher doses depending on safety and tolerability of the previous cohort
Endpoints not related to the safety reviews will be analyzed after the last patient last visit LPLV
Subjects will be randomized at a 62 ratio of either MANP or placebo and will be stratified by race in each dosage cohort The entire first Cohort will be given the lowest dosage with subsequent cohorts progressing sequentially to the higher doses depending on safety and tolerability of the previous cohort
Endpoints not related to the safety reviews will be analyzed after the last patient last visit LPLV
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