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A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation

NCT ID: NCT07217067

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-28

Study Completion Date

2027-09-09

Brief Summary

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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 fibrillaiton

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation Atrial fibrillation burden Arrythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PKN605 lower dose

PKN605 is an oral fomulation

Group Type EXPERIMENTAL

PKN605

Intervention Type DRUG

PKN605 is an oral formulation

PKN605 higher dose

PKN605 is an oral formulation

Group Type EXPERIMENTAL

PKN605

Intervention Type DRUG

PKN605 is an oral formulation

Placebo

Placebo is an oral formulation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo

Interventions

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PKN605

PKN605 is an oral formulation

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Inclusions at Screening

* Signed informed consent must be obtained prior to participation in the study
* Male and female participants ≥ 18 years of age
* History of at least 2 episodes of AF
* At least 1 of the AF episodes specified in inclusion #3 must be within the last 12 months (or during screening) and documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator
* One or more 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
* CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)
* Stable heart failure or with New York Heart Association class I or II symptoms
* NT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months

* On guideline-directed stroke prevention treatment, as confirmed by the Investigator
* Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated as body weight (kg) divided by height (m) squared
* Inclusions at Day 1

* Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)

Exclusion Criteria

-Exclusions at Screening

* Permanent AF
* 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 within the last 6 months 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
* Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Weill Cornell Medical Center

New York, New York, United States

Site Status RECRUITING

Novartis Investigative Site

Newmarket, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Québec, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Goes, Zeeland, Netherlands

Site Status RECRUITING

Novartis Investigative Site

Singapore, Singapore, Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Countries

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United States Canada Netherlands Singapore

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

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Salem Fasil

Role: primary

Other Identifiers

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CPKN605A12201

Identifier Type: -

Identifier Source: org_study_id