Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299826
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-02-16
Brief Title:
A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase IIb Two-Cohort Randomised Placebo-controlled Double-blind Multi-centre Dose-ranging Study of AZD5462 in Stable Patients With Chronic Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-09
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:
LUMINARA
Brief Summary:
The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure HF
Detailed Description:
This is a Phase IIb randomized double-blind placebo-controlled multi-center dose-ranging study to evaluate the efficacy safety and pharmacokinetic PK of AZD5462 on top of standard of care in 2 cohorts of participants with HF Cohort A and Cohort B
The study will include 3 periods and approximately 12 study visits
Screening period of up to 4 weeks at least 1 study visit
Treatment period of 24 weeks 8 study visits
Follow-up period of 4 weeks 3 study visits
Eligible participants in each cohort will be randomized equally 1111 to receive a once daily dose OD of 3 dose levels low medium or high oral dose of AZD5462 tablets or placebo
The study will include 3 periods and approximately 12 study visits
Screening period of up to 4 weeks at least 1 study visit
Treatment period of 24 weeks 8 study visits
Follow-up period of 4 weeks 3 study visits
Eligible participants in each cohort will be randomized equally 1111 to receive a once daily dose OD of 3 dose levels low medium or high oral dose of AZD5462 tablets or placebo
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