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Looking for participantsPhase2

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

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT07217067

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
PKN605 (drug), Placebo (other)
How long the study runs
Study runs about 23 months (dates as stated)
About the drug or intervention
PKN605 — drug: PKN605 is an oral formulation · Placebo — other: Matching placebo
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
165
Started
2025-10-28
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for atrial fibrillation
  • • Phase2 - 165 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with atrial fibrillation

Where?

  • • Brighton - Novartis Investigative Site
  • • Newcastle upon Tyne - Novartis Investigative Site
  • • Liverpool - Novartis Investigative Site
  • • London - Novartis Investigative Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Atrial Fibrillation

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ a body mass index (BMI) ≥ 18 kg/m2

What the study is looking for

  • ✓Inclusions at Screening
  • ✓Signed agreement to take part 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 (atrial fibrillation or atrial flutter), at least one episode must be atrial...
  • ✓One or more of the following:

Who cannot take part

  • ✗Exclusions at Screening
  • ✗Permanent AF
  • ✗Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF,...
  • ✗History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.
  • ✗Implanted pacemaker, defibrillator, or heart monitor
See the full criteria
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 (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrillation * 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 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 * Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening

Where Is This Study? (4 UK sites)

Novartis Investigative Site

Brighton BN2 5BE, United Kingdom

Recruiting

Novartis Investigative Site

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting

Novartis Investigative Site

Liverpool L14 3PE, United Kingdom

WITHDRAWN

Novartis Investigative Site

London W12 0HS, United Kingdom

Recruiting

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111
Data sourced from ClinicalTrials.gov · Last verified: 2026-09