RecruitingPhase 2interventionalRules rewrite

Phase 2: testing PKN605 for Atrial Fibrillation

A randomly assigned, compared with a dummy treatment, participant-and investigator-blinded study to measure the how well it works in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation

Official registry: https://clinicaltrials.gov/study/NCT07217067 · Novartis Pharmaceuticals · enrollment listed as 165

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are PKN605, or Placebo. The registry lists allocation as randomized. A randomly assigned, compared with a dummy treatment, participant-and investigator-blinded study to measure the how well it works in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation

They plan to enroll about 165 people at 34 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation

Interventions: PKN605, Placebo

Primary outcome (registry wording): Atrial fibrillation burden from ECG patch monitors

Who it is for (from inclusion criteria)

Ages 18 Years to any
Inclusions at Screening
Male and female participants ≥ 18 years of age
History of atrial fibrillation
AF (atrial fibrillation or atrial flutter) within the last 12 months (or during screening) documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator
Meets one or more of the following criteria:
A. Recurrent AF (≥ 2 episodes), and ≥ 1 of the following
AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months

Who the registry excludes

Exclusions at Screening
Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)
Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)
History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation
Implanted pacemaker, defibrillator, or cardiac monitor
Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy
Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used

Public study contact (from the registry)

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

34 listed

Cardiology Associates of North MS — Tupelo, Mississippi (recruiting)
Cooper University Hospital — Camden, New Jersey (recruiting)
Weill Cornell Medical Center — New York, New York (recruiting)
Duke Univ Medical Center — Durham, North Carolina (recruiting)
Intermountain Medical Center — Murray, Utah (recruiting)
Swedish Heart and Vascular Clinic — Seattle, Washington (recruiting)

+ 28 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07217067 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07217067?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07217067?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary