Multiple clinical trials spanning Phase 1 through Phase 4 evaluate sotalol for cardiovascular indications, including atrial fibrillation, atrial arrhythmias, ventricular tachycardia, long QT syndrome, and drug toxicity. Sponsored by academic medical centers, research organizations, and pharmaceutical companies such as AltaThera Pharmaceuticals, Massachusetts General Hospital, and Pharmtechnology LLC, these studies examine intravenous formulations, bioequivalence, antiarrhythmic efficacy, pharmacokinetics, and shock prophylaxis. Displaying statuses ranging from active and completed to terminated or not yet recruiting, these investigations comprehensively assess safety and efficacy in patients with complex cardiac conditions.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06322017 | RECRUITING | Atrial Fibrillation |
Nantes University Hospital |
2024-04-09 | |
| NCT07405671 | NOT_YET_RECRUITING | Atrial Fibrillation (AF); Coronary Artery Disease |
Universitaire Ziekenhuizen KU Leuven |
2026-09 | PHASE4 |
| NCT06669299 | RECRUITING | Ventricular Tachycardia (VT) |
IRCCS Ospedale San Raffaele |
2025-06-12 | |
| NCT05939076 | NOT_YET_RECRUITING | Atrial Fibrillation, Persistent |
Region Örebro County |
2023-08-21 | PHASE3 |
| NCT02347111 | RECRUITING | Atrial Fibrillation |
University of Illinois at Chicago |
2020-12-31 | PHASE4 |
| NCT06096337 | ACTIVE_NOT_RECRUITING | Persistent Atrial Fibrillation |
Boston Scientific Corporation |
2023-12-28 | |
| NCT04942834 | COMPLETED | Atrial Fibrillation, Persistent; Arrhythmias, Cardiac |
Ruijin Hospital |
2021-10-01 | |
| NCT02624765 | COMPLETED | Fetal Atrial Flutter Without Hydrops; Fetal Supraventricular Tachycardia Without Hydrops; Fetal Supraventricular Tachycardia With Hydrops |
Edgar Jaeggi |
2016-02 | PHASE3 |
| NCT05418036 | UNKNOWN | Supraventricular Arrhythmia; Ventricular Arrythmia; Proarrhythmia; Antiarrhythmic Drug Adverse Reaction |
University of Sao Paulo General Hospital |
2020-10-26 | PHASE4 |
| NCT03845010 | COMPLETED | Ventricular Premature Beats |
Maatschap Cardiologie Zwolle |
2019-02-12 | |
| NCT04473807 | UNKNOWN | Arrhythmias, Cardiac; Atrial Fibrillation |
Kansas City Heart Rhythm Research Foundation |
2021-01-02 | PHASE4 |
| NCT05247320 | Completed | Atrial Arrhythmia |
University of Utah|AltaThera Pharmaceuticals LLC |
2022-02-04 | -- |
| NCT03895411 | UNKNOWN | Arrhythmia |
Shengjing Hospital |
2019-08 | PHASE4 |
| NCT02389218 | COMPLETED | Atrial Fibrillation |
University Hospital, Ghent |
2015-03-03 | PHASE4 |
| NCT03799536 | COMPLETED | Bioequivalence |
Pharmtechnology LLC |
2019-01-09 | PHASE1 |
| NCT03799536 | Completed | Bioequivalence |
Pharmtechnology LLC|National Anti-Doping Labaratory |
2019-01-09 | Phase 1 |
| NCT02294955 | UNKNOWN | Atrial Fibrillation; Quality of Life |
Uppsala University Hospital |
2008-05 | |
| NCT02145546 | UNKNOWN | Atrial Fibrillation |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
2014-05 | PHASE4 |
| NCT02153437 | TERMINATED | Atrial Fibrillation |
Bristol-Myers Squibb |
2014-10-30 | PHASE1 |
| NCT01798277 | WITHDRAWN | Ventricular Tachycardia; Coronary Artery Disease |
Newmarket Electrophysiology Research Group Inc |
2013-04 | PHASE3 |
| NCT01576042 | TERMINATED | Ventricular Tachycardia |
Duke University |
2012-05 | |
| NCT01780311 | UNKNOWN | Ventricular Tachycardia; Ventricular Premature Complexes |
Ospedale San Donato |
2013-01 | PHASE4 |
| NCT00773201 | COMPLETED | Healthy Volunteers |
Assistance Publique - Hôpitaux de Paris |
2008-02 | PHASE1 |
| NCT01709682 | COMPLETED | Paroxysmal Atrial Fibrillation; Failed First Radiofrequency Ablation Procedure |
Meshalkin Research Institute of Pathology of Circulation |
2007-11 | PHASE2 |
| NCT01338441 | Completed | Cardiology: RR / QT |
Ectycell SASU|Pierre and Marie Curie University|Institut National de la Santé Et de la Recherche Médicale France |
2011-03 | Phase 1 |
| NCT01097330 | Terminated | Defibrillators Implantable|Tachycardia Ventricular |
Population Health Research Institute|Abbott Medical Devices|Hamilton Health Sciences Corporation |
2010-08 | Phase 3 |
| NCT00523978 | COMPLETED | Paroxysmal Atrial Fibrillation |
Medtronic Cardiac Rhythm and Heart Failure |
2006-10 | PHASE3 |
| NCT00408200 | COMPLETED | Atrial Fibrillation |
University of Pennsylvania |
2006-11 | |
| NCT00540787 | COMPLETED | Paroxysmal Atrial Fibrillation |
Biosense Webster, Inc. |
2003-08-01 | PHASE4 |
| NCT00035451 | COMPLETED | Atrial Fibrillation |
Forest Laboratories |
2001-02 | PHASE3 |
| NCT00007605 | COMPLETED | Atrial Fibrillation; Cerebrovascular Accident; Death, Sudden |
US Department of Veterans Affairs |
1998-04 | PHASE3 |
| NCT00000464 | COMPLETED | Arrhythmia; Cardiovascular Diseases; Heart Arrest; Heart Diseases; Myocardial Infarction; Ventricular Fibrillation |
University of Washington |
1987-04 | PHASE3 |
| NCT00000556 | COMPLETED | Arrhythmia; Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases |
National Heart, Lung, and Blood Institute (NHLBI) |
1995-03 | PHASE3 |
| NCT00000518 | COMPLETED | Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Tachycardia, Ventricular; Ventricular Arrhythmia; Ventricular Fibrillation |
University of Utah |
1985-07 | PHASE3 |
| NCT00000531 | COMPLETED | Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Tachycardia, Ventricular; Ventricular Fibrillation |
National Heart, Lung, and Blood Institute (NHLBI) |
1992-09 | PHASE3 |
| NCT00257959 | COMPLETED | Ventricular Tachycardia |
Connolly, Stuart, M.D. |
2001-01 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2025-04-29)
Check the
Sotalol HCl
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.