NCT06540352

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

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 Fibrillation/Flutter After Terminating Its Persistent Form

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Refralon® tablets in two different doses (1 or 2 tablets per day) will be evaluated vs. placebo in patients with persistent atrial fibrillation/flutter 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.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-08-06
• Last updated: 2026-04-08

Locations

1 site across 1 country: Russia