Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737940
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-01-20
Brief Title:
A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase IIb Randomised Double-blind Placebo-controlled Multi-centre Dose-ranging Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Due to Left Heart Disease WHO Group 2
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Re-PHIRE
Brief Summary:
This study is intended to assess the ability of AZD3427 to reduce pulmonary vascular resistance PVR after 24 weeks of treatment in participants with heart failure HF and pulmonary hypertension PH Group 2
Detailed Description:
This study is a randomized placebo-controlled multi-centre dose-ranging study of AZD3427 in participants with heart failure and pulmonary hypertension due to left heart disease World Health Organisation WHO Group 2
Approximately 220 participants will be randomised to 4 treatment groups in a 1111 ratio to receive a subcutaneous SC injection of AZD3427 or placebo every 2 weeks for 24 weeks
This study will evaluate 3 dose levels of AZD3427 Dose A Dose B and Dose C Dose modification is not applicable for this study
The study will be conducted in approximately 60 study centres across an estimated 15 countries
The study will include approximately 16 study visits 2 visits during the Screening Period13 visits during the Treatment Period and one visit during the Follow-up Period
The expected total duration of the study is 32 to 37 weeks depending on the length of the Screening Period
Approximately 220 participants will be randomised to 4 treatment groups in a 1111 ratio to receive a subcutaneous SC injection of AZD3427 or placebo every 2 weeks for 24 weeks
This study will evaluate 3 dose levels of AZD3427 Dose A Dose B and Dose C Dose modification is not applicable for this study
The study will be conducted in approximately 60 study centres across an estimated 15 countries
The study will include approximately 16 study visits 2 visits during the Screening Period13 visits during the Treatment Period and one visit during the Follow-up Period
The expected total duration of the study is 32 to 37 weeks depending on the length of the Screening Period
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