Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582409
Status:
TERMINATED
Last Update Posted:
2024-06-20
First Post:
2020-10-07
Brief Title:
A Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Placebo-controlled Investigator- and Participant-blinded Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a randomized placebo-controlled investigator- and participant-blinded study to evaluate the efficacy safety tolerability and pharmacokinetics PK of HSY244 in participants with atrial fibrillation AF with and without heart failure HF
Detailed Description:
A screening period of up to 3 days 72 hours was used to assess eligibility After eligibility was confirmed patients were randomized to either HSY244 or placebo Prior to study drug administration pre-dose assessments were completed After the start of study drug administration the participant was monitored for cardioversion to sinus rhythm If a participant was still in AF at 90 minutes after the start of study drug administration direct current cardioversion was planned to be applied at a time deemed appropriate by the investigator
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004327-17 | EUDRACT_NUMBER | None | None |