Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06307652
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-02-06
Brief Title:
Study to Evaluate the Effect of BalcinrenoneDapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Randomised Double-blind Study to Evaluate the Effect of BalcinrenoneDapagliflozin Compared With Dapagliflozin on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
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:
BalanceD-HF
Brief Summary:
This is a Phase III international multi-centre randomised double-blind parallel-group double-dummy active-controlled event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event The aim is to evaluate the effect of balcinrenonedapagliflozin vs dapagliflozin given once daily on top of other classes of SoC on CV death and HF events
Detailed Description:
The purpose of this study is to investigate the effect of balcinrenonedapagliflozin compared with dapagliflozin on the risk of CV death HF event with and without hospitalisation in patients with chronic HF impaired kidney function and who have had a recent HF event
Eligible patients will randomly be assigned with a 111 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments
1 Balcinrenonedapagliflozin 15 mg10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
2 Balcinrenonedapagliflozin 40 mg10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
3 Dapagliflozin 10 mg tablet and matching placebo for balcinrenonedapagliflozin capsule
The study is event driven and the average study duration for a participant is estimated to be 22 months including screening period 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin
The study will be conducted at approximately 700 sites in approximately 40 countries globally
Eligible patients will randomly be assigned with a 111 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments
1 Balcinrenonedapagliflozin 15 mg10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
2 Balcinrenonedapagliflozin 40 mg10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
3 Dapagliflozin 10 mg tablet and matching placebo for balcinrenonedapagliflozin capsule
The study is event driven and the average study duration for a participant is estimated to be 22 months including screening period 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin
The study will be conducted at approximately 700 sites in approximately 40 countries globally
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