A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
NCT ID: NCT04571385
Last Updated: 2024-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2019-09-09
2023-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: AP30663
Participants will receive single dose of AP30663.
AP30663
Administer by intravenous infusion.
Part 1: Placebo
Participants will receive placebo matched to AP30663.
Placebo
Placebo matched to AP30663.
Part 2: AP30663
Participants will receive a single dose of one of the multiple dose levels of AP30663.
AP30663
Administer by intravenous infusion.
Part 2: Placebo
Participants will receive placebo matched to AP30663.
Placebo
Placebo matched to AP30663.
Interventions
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AP30663
Administer by intravenous infusion.
Placebo
Placebo matched to AP30663.
Eligibility Criteria
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Inclusion Criteria
* Current episode of symptomatic AF lasting between 3-hour and 7 days (inclusive) at randomization
* Adequate anticoagulation according to international and/or national guidelines
Exclusion Criteria
* History of significant mental, renal or hepatic disorder, chronic obstructive pulmonary disease, sinus nodal disease, or other significant disease, as judged by the investigator.
* Any cardioversion attempt of AF or atrial flutter within 4 weeks preceding randomization
* Use of any antiarrhythmic drug class I and/or III within 6 months before randomisation
18 Years
80 Years
ALL
No
Sponsors
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Acesion Pharma
INDUSTRY
Responsible Party
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Locations
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Acesion Pharma Investigational Site 110
Aalborg, , Denmark
Acesion Pharma Investigational Site 106
Copenhagen, , Denmark
Acesion Pharma Investigational Site 108
Hellerup, , Denmark
Acesion Pharma Investigational Site 113
Hillerød, , Denmark
Acesion Pharma Investigational Site 105
Roskilde, , Denmark
Acesion Pharma Investigational Site 202
Budapest, , Hungary
Acesion Pharma Investigational Site 203
Budapest, , Hungary
Acesion Pharma Investigational Site 207
Budapest, , Hungary
Acesion Pharma Investigational Site 212
Budapest, , Hungary
Acesion Pharma Investigational Site 213
Budapest, , Hungary
Acesion Pharma Investigational Site 214
Budapest, , Hungary
Acesion Pharma Investigational Site 211
Pécs, , Hungary
Acesion Pharma Investigational Site 201
Szekszárd, , Hungary
Acesion Pharma Investigational Site 210
Szentes, , Hungary
Acesion Pharma Investigational Site 204
Zalaegerszeg, , Hungary
Countries
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References
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Holst AG, Tomcsanyi J, Vestbjerg B, Grunnet M, Sorensen US, Diness JG, Bentzen BH, Edvardsson N, Hohnloser SH, Bhatt DL, Dorian P. Inhibition of the KCa2 potassium channel in atrial fibrillation: a randomized phase 2 trial. Nat Med. 2024 Jan;30(1):106-111. doi: 10.1038/s41591-023-02679-9. Epub 2023 Dec 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004445-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AP30663-2001
Identifier Type: -
Identifier Source: org_study_id
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