A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation
Part of paid clinical trials in Tupelo, Mississippi.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07217067
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PKN605 — DRUGPKN605 is an oral formulation
- Placebo — OTHERMatching placebo
Study Details
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
Key Dates
- Start date
- Oct 28, 2025
- Status verified
- May 2026
- Primary completion
- Sep 9, 2027
- Completion
- Sep 9, 2027
Study Design
- Enrollment
- 165 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: PKN605 lower dosePKN605 is an oral formulation
- Experimental: PKN605 higher dosePKN605 is an oral formulation
- Placebo Comparator: PlaceboPlacebo is an oral formulation
Primary Outcome Measure
Atrial fibrillation burden from ECG patch monitors [ Time Frame: 24 weeks ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cardiology Associates of North MS | Tupelo | Mississippi | 38801 | Brittany Cook James Edgar Stone (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medical Center | New York | New York | 10021 | Penn Collins Jim Way Cheung (PRINCIPAL_INVESTIGATOR) |
| Duke Univ Medical Center | Durham | North Carolina | 27710 | Jessalyn Davis Jonathan Piccini (PRINCIPAL_INVESTIGATOR) |
| Intermountain Medical Center | Murray | Utah | 84107 | Paden Hansen Michael Cutler (PRINCIPAL_INVESTIGATOR) |
| Swedish Heart and Vascular Clinic | Seattle | Washington | 98122 | David Lam (PRINCIPAL_INVESTIGATOR) |
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