A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation
Start Date
10/28/2025
Completion Date
9/9/2027
Summary
A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation
Detailed Description
A screening period of up to 90 days will be conducted to determine participants' eligibility. Once eligibility is confirmed, participants will be randomly assigned to receive either PKN605 or placebo. The treatment phase will last for 24 weeks, during which participants will visit the clinic approximately once a month. During the study, participants' atrial fibrillation will be monitored using various ECG devices. Approximately one month after the end of the treatment phase, participants will have a final safety follow-up visit. The primary purpose of the study is to monitor the effect PKN605 has on the amount of time participants spend in atrial fibrillation.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PKN605
Placebo
Conditions
Locations
Cardiology Associates of North MS
Tupelo, Mississippi 38801
United States
Cooper University Hospital
Camden, New Jersey 08103
United States
Weill Cornell Medical Center
New York, New York 10021
United States
Duke Univ Medical Center
Durham, North Carolina 27710
United States
Intermountain Medical Center
Murray, Utah 84107
United States
Swedish Heart and Vascular Clinic
Seattle, Washington 98122
United States
Novartis Investigative Site
Calgary, Alberta T2P 3C5
Canada
Novartis Investigative Site
Vancouver, British Columbia V5Z 1M9
Canada
Novartis Investigative Site
Halifax, Nova Scotia B3H 3A7
Canada
Novartis Investigative Site
Hamilton, Ontario L8L 2X2
Canada
Novartis Investigative Site
London, Ontario N6A 5W9
Canada
Novartis Investigative Site
Newmarket, Ontario L3Y 2P6
Canada
Novartis Investigative Site
Toronto, Ontario M4N 3M5
Canada
Novartis Investigative Site
Toronto, Ontario M5B 1W8
Canada
Novartis Investigative Site
Montreal, Quebec H1T 1C8
Canada
Novartis Investigative Site
Montreal, Quebec H2X 1R9
Canada
Novartis Investigative Site
Montreal, Quebec H4A 3J1
Canada
Novartis Investigative Site
Québec, Quebec G1V 4G5
Canada
Novartis Investigative Site
Sherbrooke, Quebec J1H 5N4
Canada
Novartis Investigative Site
Beijing, Beijing Municipality 100013
China
Novartis Investigative Site
Beijing, 100730
China
Novartis Investigative Site
Xi'an, 223001
China
Novartis Investigative Site
Bad Homburg, 61348
Germany
Novartis Investigative Site
Berlin, 10787
Germany
Novartis Investigative Site
Berlin, 13353
Germany
Novartis Investigative Site
Hamburg, 20099
Germany
Novartis Investigative Site
Hamburg, 20246
Germany
Novartis Investigative Site
Arnhem, Gelderland 6815 AD
Netherlands
Novartis Investigative Site
Maastricht, Limburg 6229 HX
Netherlands
Novartis Investigative Site
Delft, South Holland 2625 AD
Netherlands
Novartis Investigative Site
Goes, Zeeland 4462 RA
Netherlands
Novartis Investigative Site
Groningen, 9713 GZ
Netherlands
Novartis Investigative Site
Veldhoven, 5504 DB
Netherlands
Novartis Investigative Site
Singapore, Singapore S308433
Singapore
Novartis Investigative Site
Singapore, 119074
Singapore
Novartis Investigative Site
Singapore, 169609
Singapore
Novartis Investigative Site
Brighton, East Sussex BN2 5BE
United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear NE7 7DN
United Kingdom
Novartis Investigative Site
Liverpool, L14 3PE
United Kingdom
Novartis Investigative Site
London, W12 0HS
United Kingdom