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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582409
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: HSY244 Other: Placebo Phase 2

Detailed Description:

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

Participants will be randomized and assigned to one of the following 2 treatment arms in a ratio of 1:1:

Arm 1: HSY244 intravenous infusion Arm 2: Placebo intravenous infusion

The study consists of a screening period of up to 3 days and a treatment period of 4 days. After confirming eligibility on Day 1 and pre-dose assessments are completed, study administration will occur and participants will be monitored for cardioversion to sinus rhythm. During the treatment period, participants will be evaluated for efficacy, safety, tolerability, and pharmacokinetics.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Investigator- and Participant-blinded Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : February 9, 2022
Estimated Study Completion Date : February 9, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HSY244
HSY244 concentrate solution for injection via intravenous infusion
Drug: HSY244
HSY244 concentrate solution for injection via intravenous infusion

Placebo Comparator: Placebo
Placebo concentrate solution for injection via intravenous infusion
Other: Placebo
concentrate solution for injection via intravenous infusion




Primary Outcome Measures :
  1. Conversion to sinus rhythm for at least 1 minute within 90 minutes from the start of study drug administration [ Time Frame: 1 day ]
    Conversion to sinus rhythm will be monitored using a Holter monitoring device through 90 minutes after drug administration.


Secondary Outcome Measures :
  1. Maximum Observed Serum Concentration (Cmax) [ Time Frame: 4 days ]
    The Cmax is the observed maximum plasma concentration following administration.

  2. Time to Reach the Maximum Concentration After Drug Administration (Tmax) [ Time Frame: 4 days ]
    Tmax is the time to reach peak or maximum concentration after drug administration

  3. Area under the plasma concentration-time curve (AUClast) [ Time Frame: 4 days ]
    AUClast is the area under the plasma concentration-time curve following drug administration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582409


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Novartis Investigative Site Recruiting
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04582409    
Other Study ID Numbers: CHSY244X2201
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
atrial fibrillation
arrhythmia
pharmacological cardioversion
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes