FlecIH-103 (flecainide acetate inhalation solution) for Atrial Fibrillation

The Valley Hospital, Inc, Ridgewood, NJ
Atrial FibrillationPlacebo - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

Study Summary

This trial will evaluate if Flecainide Acetate, when inhaled, is more effective than a placebo in treating patients with recent onset atrial fibrillation. Approximately 400 people will be enrolled in the study and will be given either the drug or the placebo. The study will last for 24 weeks.

Eligible Conditions
  • Atrial Fibrillation

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 90 minutes

90 minutes
Assessing and comparing the AF-related interventions prior to discharge between the active vs. placebo
Assessing and comparing the hospital admissions between the active vs. placebo
Assessing and comparing the time of discharge
Assessment of proportion of patients whose AF converts using continuous ECG monitoring
Time of conversion to be monitored using continuous ECGs
90 minutes post dose
Assessing and comparing the AF related symptoms by using a questionnaire

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

FlecIH-103 (flecainide acetate inhalation solution)
1 of 2
Vehicle-matched inhalation solution (placebo)
1 of 2

Active Control

Non-Treatment Group

400 Total Participants · 2 Treatment Groups

Primary Treatment: FlecIH-103 (flecainide acetate inhalation solution) · Has Placebo Group · Phase 3

FlecIH-103 (flecainide acetate inhalation solution)
Drug
ActiveComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Vehicle-matched inhalation solution (placebo)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 90 minutes

Who is running the clinical trial?

InCarda Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
170 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
170 Patients Enrolled for Atrial Fibrillation
Luiz Belardinelli, MDStudy DirectorInCarda Therapeutics, Inc.
1 Previous Clinical Trials
170 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
170 Patients Enrolled for Atrial Fibrillation

Eligibility Criteria

Age 18 - 85 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
"Newly diagnosed AF" means that you have been diagnosed with atrial fibrillation for the first time, regardless of how long you have had it.

Frequently Asked Questions

Is FlecIH-103 (flecainide acetate inhalation solution) an FDA-verified medication?

"The safety of FlecIH-103 has been well documented in Phase 3 trials, so it received a score of 3 from our Power team." - Anonymous Online Contributor

Unverified Answer

Are people with the specific ailment needed for this clinical trial able to participate at this time?

"The study is looking for participants and has all the necessary information posted on clinicaltrials.gov. The trial was first posted on 4/26/2022 and updated on the same day, meaning that the data is recent and reliable." - Anonymous Online Contributor

Unverified Answer

Does this research exclude patients that are middle-aged or older?

"The age limit for patients participating in this study is 85 years old. So long as they are above 18, any patient is welcome." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.