Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540352
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
A Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon Tablets 1 mg for Long-term Use to Prevent Recurrence of Atrial FibrillationFlutter After Terminating Its Persistent Form
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Parallel Group Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon Tablets 1 mg Pharmproekt JSC for Long-term Use to Prevent Recurrence of Atrial FibrillationFlutter After Terminating Its Persistent Form
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Refralon tablets in two different doses 1 or 2 tablets per day will be evaluated vs placebo in patients with persistent atrial fibrillationflutter after synus rhythm restoration in order to prevent recurrence of arrhythmia Efficacy and safety of Refralon tablets will be studied its optimal dose will be selected and its pharmacokinetics will be evaluated in 14 days 1 3 and 6 months
Detailed Description:
None
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