NCT06540352View on ClinicalTrials.gov

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 Fibrillation/Flutter After Terminating Its Persistent Form

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 3, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Atrial FibrillationAtrial Flutter
Interventions
DRUG

4-Nitro-N-[(1RS)-1-(4-fluorophenyl)-2-(1-ethylpiperidin-4-yl)ethyl]benzamide hydrochloride

The drug Refralon® (n-1-\[(4-fluorophenyl)-2-(1-ethyl-4-piperidyl)-ethyl\]-4-nitrobenzamide hydrochloride) in the dosage form of a concentrate for the preparation of a solution for intravenous administration is registered for medical use in RF June 24, 2014, re-registration was successfully completed on November 20, 2019, registration certificate LP 002510, until December 31, 2025.

DRUG

Mannitol

Placebo in tablets

Trial Locations (1)

Unknown

RECRUITING

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization, Moscow

All Listed Sponsors
lead

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV