Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | RYTHMOL | — | 1997-12-23 | fda.gov ↗ |
| Approved | US (FDA) | RYTHMOL | — | 1989-11-27 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT00000556 | Mar 1995 → Sep 2002 | atrial fibrillation | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000464 | Apr 1987 → Dec 1992 | cardiac arrest, myocardial infarction, ventricular fibrillation | University of Washington | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02145546 | May 2014 → May 2017 | atrial fibrillation | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01505296 | Dec 2011 → Jan 2014 | atrial fibrillation | Valley Health System | Withdrawn | No outcome recorded |
| Phase not applicable7 trials · 4 met primary | ||||||
| — | NCT07447297 | Jan 2024 → Dec 2027 expected | atrial fibrillation, atrial flutter | Samsung Medical Center | Recruiting | No outcome recorded |
| — | NCT03674658 | Jul 2019 → Aug 2021 | atrial fibrillation | TSH Biopharm Corporation Limited | Completed | Met primary |
| — | NCT02825979 | Jan 2017 → Sep 2022 | atrial fibrillation | Jason Andrade | Unknown | Met primary |
| — | NCT03561935 | Jun 2015 → Jun 2019 | cardiovascular disorder | Yong Seog Oh | Withdrawn | No outcome recorded |
| — | NCT02051621 | Aug 2010 → Aug 2015 | atrial fibrillation, atrial flutter | University of Rostock | Unknown | Met primary |
| — | NCT00408200 | Nov 2006 → Apr 2008 | paroxysmal atrial fibrillation | University of Pennsylvania | Completed | Met primary |
| — | NCT00578617 | Sep 2006 → Feb 2009 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| Comparator or background therapy30 trials | ||||||
| Phase 2 | NCT01709682 Comparator | Nov 2007 → Jan 2012 | paroxysmal atrial fibrillation | Meshalkin Research Institute of Pathology of Circulation | Completed | No outcome recorded |
| Phase 3 | NCT05939076 Comparator | Aug 2023 → Dec 2027 expected | persistent atrial fibrillation | Region Örebro County | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04037397 Comparator | Sep 2019 → Oct 2024 | atrial fibrillation | University of Pennsylvania | Completed | No outcome recorded |
| Phase 3 | NCT00589303 Comparator | Dec 2007 → Jul 2011 | atrial fibrillation, heart failure | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00523978 Comparator | Oct 2006 → Aug 2010 | paroxysmal atrial fibrillation | Medtronic Cardiac Rhythm and Heart Failure | Completed | No outcome recorded |
| Phase 3 | NCT00392106 Comparator | Apr 2006 → Dec 2010 | atrial fibrillation | ProRhythm, Inc. | Suspended | No outcome recorded |
| Phase 4 | NCT07270848 Comparator | Jan 2026 → Jun 2028 expected | atrial fibrillation | Inha University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05720572 Comparator | Sep 2019 → Sep 2025 | atrial fibrillation | Centre of Postgraduate Medical Education | Unknown | No outcome recorded |
| Phase 4 | NCT03895411 Comparator | Aug 2019 → Dec 2020 | cardiac rhythm disease | Shengjing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03029169 Comparator | Oct 2017 → Jul 2022 | cardiac rhythm disease, infectious disease with sepsis | Charles University, Czech Republic | Completed | No outcome recorded |
| Phase 4 | NCT02389218 Comparator | Mar 2015 → May 2020 | atrial fibrillation | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT01780311 Comparator | Jan 2013 → Jan 2014 | ventricular tachycardia | Ospedale San Donato | Unknown | No outcome recorded |
| Phase 4 | NCT01477983 Comparator | Nov 2011 → Jul 2017 | atrial fibrillation | Kyoto University, Graduate School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00540787 Comparator | Aug 2003 → Jun 2006 | paroxysmal atrial fibrillation | Biosense Webster, Inc. | Completed | No outcome recorded |
| — | NCT06699342 Comparator | Jan 2025 → Dec 2027 expected | atrial fibrillation | Seoul National University Hospital | Recruiting | No outcome recorded |
| — | NCT05993897 Comparator | Aug 2024 → Jun 2025 | atrial fibrillation | Aswan University | Completed | No outcome recorded |
| — | NCT06096337 Comparator | Dec 2023 → Feb 2026 overdue | persistent atrial fibrillation | Boston Scientific Corporation | Active not recruiting | No outcome recorded |
| — | NCT06125925 Comparator | Nov 2023 → Nov 2026 expected | atrial fibrillation, heart failure | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| — | NCT05790707 Comparator | Apr 2023 → Jan 2027 expected | cognitive impairment with or without cerebellar ataxia, persistent atrial fibrillation | Poitiers University Hospital | Recruiting | No outcome recorded |
| — | NCT04942834 Comparator | Oct 2021 → Jul 2025 | persistent atrial fibrillation | Ruijin Hospital | Unknown | No outcome recorded |
| — | NCT03437356 Comparator | Feb 2018 → May 2022 | atrial fibrillation | AZ Sint-Jan AV | Completed | No outcome recorded |
| — | NCT05514860 Comparator | Jan 2017 → Sep 2022 | atrial fibrillation | University of British Columbia | Unknown | No outcome recorded |
| — | NCT02633774 Comparator | Nov 2015 → Nov 2020 | persistent atrial fibrillation | Yonsei University | Unknown | No outcome recorded |
| — | NCT02459574 Comparator | May 2015 → Sep 2018 | atrial fibrillation, heart failure | Imperial College London | Completed | No outcome recorded |
| — | NCT01775891 Comparator | Jul 2012 → Jul 2015 | paroxysmal atrial fibrillation | Korea University | Unknown | No outcome recorded |
| — | NCT01713270 Background | Jul 2012 → Oct 2014 | atrial fibrillation, hypertensive disorder | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| — | NCT01991119 Comparator | May 2011 → Oct 2013 | atrial fibrillation | Samsung Medical Center | Completed | No outcome recorded |
| — | NCT00911508 Comparator | Nov 2009 → Dec 2017 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| — | NCT02294955 Comparator | May 2008 → Sep 2018 | atrial fibrillation | Uppsala University Hospital | Unknown | No outcome recorded |
| — | NCT00933634 Comparator | Jan 2006 → Nov 2008 | atrial fibrillation | Valduce Hospital | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | propafenone | “Pharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide,...” NCT06699342 ↗40“Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according...” NCT02825979 ↗ “Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according...” NCT05514860 ↗ “The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.” NCT01477983 ↗ “Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agents, propafenone, amiodarone” NCT01713270 ↗ “Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid)” NCT01775891 ↗ “or Propafenone (Rytmonorm) 600 mg single oral dose in structurally normal heart then maintenance dose of 150mg tab orally every 8 hours.” NCT05993897 ↗ “AADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone.” NCT06125925 ↗ “* procainamide * quinidine * disopyramide * propafenone * flecainide * sotalol * dofetilide * amiodarone” NCT00589303 ↗ “Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.” NCT02459574 ↗ “Propafenone: Rytmonorm or Propafenone EG 300 mg b.i.d., except 225 mg b.i.d. if ≥70 years or <70 kg” NCT03437356 ↗ |
| Known as | Propafenone EG | “Propafenone: Rytmonorm or Propafenone EG 300 mg b.i.d., except 225 mg b.i.d. if ≥70 years or <70 kg” NCT03437356 ↗ |
| Known as | Rytmonorm | “or Propafenone (Rytmonorm) 600 mg single oral dose in structurally normal heart then maintenance dose of 150mg tab orally every 8 hours.” NCT05993897 ↗3“Propafenone: Rytmonorm or Propafenone EG 300 mg b.i.d., except 225 mg b.i.d. if ≥70 years or <70 kg” NCT03437356 ↗ “dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™” NCT05939076 ↗ “propafenone (Rytmonorm ®) up to 150 mg 3 times daily” NCT02051621 ↗ |
| Route | Intravenous | “intravenous propafenone treatment” PMID 21422032 ↗ Mar 2011 |