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

A Randomized, Placebo-controlled, Investigator- and Participant-blinded Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation

ClinicalTrials.gov Identifier: NCT04582409

Novartis Reference Number: CHSY244X2201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

A randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HSY244 in participants with AF.

Condition 
Atrial Fibrillation
Phase 
Phase 2
Overall status 
Not yet recruiting
Enrollment count 
40 participants
Start date 
Oct 23, 2020
Completion date 
Sep 24, 2021
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
HSY244
HSY244 concentrate solution for injection via intravenous infusion
Other
Placebo
concentrate solution for injection via intravenous infusion

Eligibility Criteria

Inclusion Criteria:

Hemodynamically stable men and women between 18 and 75 years of age with a clinical indication for direct current cardioversion of AF
Current episode of AF has been ongoing for ≥6 hours and ≤30 days
Successful initiation and achievement of therapeutic levels of national guideline and institution-specific anticoagulation therapy as appropriate for the duration of the AF episode and risk for the participant
Completion of national guideline and institution-specific imaging evaluation for left atrial thrombi as appropriate for the duration of AF episode and risk for the participant
Participants must weigh at least 60 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 35 kg/2. BMI = Body weight (kg) / [Height (m)2]
Written informed consent must be obtained before any assessment is performed

Exclusion Criteria:

Use of any class I or III anti-arrhythmic medication, or other prohibited medications, within 5 half-lives before randomization, including use of amiodarone within 3 months before randomization
History or current diagnosis of electrocardiogram (ECG) abnormalities or cardiac rhythm disorders indicating significant risk of safety for participant as determined by the Investigator's interpretation of the ECG findings
Clinically significant sinus node dysfunction and/or presence of a permanent pacemaker
Attempted or unsuccessful cardioversion within 2 weeks prior to randomization
History of 2 or more ablation procedures for AF
Presence of known severe mitral regurgitation and/or known severely dilated left atrium
Pre-existing or tachycardia-induced moderate to severe cardiac dysfunction (New York Heart Association class III or IV)
History within the preceding 3 months prior to randomization of either a: myocardial infarction, unstable angina, cardiac surgery, or a percutaneous coronary intervention
History of confirmed stroke or transient ischemic attack (TIA)
History or current diagnosis of any seizure disorder or major neurological disorder or major psychiatric disorder
Sexually active males, including those post-vasectomy, must use a condom during sexual intercourse for at least 4 days after dosing to prevent delivery of the drug via seminal fluid and should not father a child during this period
Women must be either of non-childbearing potential or child-bearing potential using highly effective non-hormonal contraception Other protocol-defined inclusion/exclusion may apply

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]