Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639087
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase Ib Randomised Placebo-controlled Double-blind Multicentre Study to Assess the Effects and Safety of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
Status:
RECRUITING
Status Verified Date:
2024-10
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:
AURORA
Brief Summary:
A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment
Detailed Description:
This is a randomized double-blind placebo-controlled Phase 1b study to evaluate the safety pharmacodynamics and pharmacokinetics of AZD5462 on top of dapagliflozin in participants with heart failure and renal impairment
The study will include 5 periods and approximately 9 study site visits
Screening Period of up to 4 weeks at least one study visit
Run-in Period of up to 4 weeks one study visit
Inpatient Treatment Period of 4 days one study visit
Outpatient Treatment Period of up to 4 weeks three study visits
Follow-up Period of up to 4 weeks three study visits
The study will include 5 periods and approximately 9 study site visits
Screening Period of up to 4 weeks at least one study visit
Run-in Period of up to 4 weeks one study visit
Inpatient Treatment Period of 4 days one study visit
Outpatient Treatment Period of up to 4 weeks three study visits
Follow-up Period of up to 4 weeks three study visits
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