Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616974
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction the APEX Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Double-blind Randomized Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction PH-HFpEF
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TX000045-003 is a double-blind randomized parallel group placebo-controlled proof- of-concept POC study evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period the APEX study
Detailed Description:
This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms
Arm 1 Treatment Group 1 Placebo delivered subcutaneously SC every 2 weeks Q2W for 24 weeks
Arm 2 Treatment Group 2 TX000045 SC at Dose A Q2W for 24 weeks
Arm 3 Treatment Group 3 TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks
Arm 1 Treatment Group 1 Placebo delivered subcutaneously SC every 2 weeks Q2W for 24 weeks
Arm 2 Treatment Group 2 TX000045 SC at Dose A Q2W for 24 weeks
Arm 3 Treatment Group 3 TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None