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A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and day 5

Summary

This trial tests a new medication called HSY244 to help people with irregular heartbeats. It aims to see if the medication can make the heart beat normally again. If it doesn't work, an electric shock is used to try to fix the heartbeat.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and day 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and day 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Conversion to Sinus Rhythm for at Least 1 Minute Within 90 Minutes From the Start of Study Drug Administration.
Secondary study objectives
Area Under the Plasma Concentration-time Curve (AUClast)
Maximum Observed Plasma Concentration (Cmax)
Time to Reach the Maximum Concentration After Drug Administration (Tmax)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HSY244Experimental Treatment1 Intervention
HSY244 150 mg concentrate solution for injection via intravenous infusion
Group II: PlaceboPlacebo Group1 Intervention
Placebo concentrate solution for injection via intravenous infusion

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,872 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
~3 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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