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Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation

NCT05039359 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-10-30

No results posted yet for this study

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF. Approximately 400 patients are expected to be enrolled in this study. Patients will be randomized 3:1 to receive FlecIH-103 at a total dose of up to 120 mg estimated total lung dose (eTLD) (n=300) or placebo inhalation solution (n=100). Randomization will be stratified by geographic region (US and ex-US) and duration of symptoms of the current AF episode (≥1 hour to ≤24 hours and \>24 hours to ≤48 hours).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DRUG

FlecIH-103

flecainide acetate inhalation solution

Sponsors & Collaborators

  • InCarda Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Luiz Belardinelli, MD · InCarda Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2023-05-22
Completion
2023-05-22
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Hungary
  • Netherlands
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05039359 on ClinicalTrials.gov