Amiodarone

Generic Name: Amiodarone

Brand Names: Nexterone, Pacerone

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₉I_₂NO_₃

CAS Number: 1951-25-3

Unique Ingredient Identifier: N3RQ532IUT

Background: Amiodarone is a benzofuran derivative, anti-arrhythmic drug used commonly in a variety of settings. Most known for its approved indication in life-threatening ventricular arrhythmias, it is also used off-label in the outpatient and inpatient setting for atrial fibrillation. Because of its ability to cause serious toxicity and possibly death, amiodarone use should be reserved for its approved indications, according to prescribing information.

Indication: The FDA approved indications for amiodarone are recurrent ventricular fibrillation (VF) and recurrent hemodynamically unstable ventricular tachycardia (VT). The FDA emphasizes that this drug should only be given in these conditions when they are clinically documented and have not responded to normal therapeutic doses of other antiarrhythmic agents, or when other drugs are not tolerated by the patient.

Off-label indications include atrial fibrillation and supraventricular tachycardia.

Associated Conditions: Atrial Fibrillation, Supraventricular Tachycardia (SVT), Recurrent Ventricular fibrillation, Recurrent hemodynamically unstable Ventricular tachycardia

Associated Therapies: -

Clinical Trials

Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter

Phase 2

Completed

Conditions: Atrial Fibrillation
Atrial Flutter

Interventions: Drug: Betrixaban 90 mg
Drug: Betrixaban 60 mg
Drug: Amiodarone
Drug: Betrixaban 30 mg

First Posted Date: 2010-10-27

Last Posted Date: 2023-08-07

Lead Sponsor: Portola Pharmaceuticals

Target Recruit Count: 189

Registration Number: NCT01229254

n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation

Phase 3

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: n-3 PUFAs
Drug: Placebo
Drug: RASS inhibitors and/or RAS blockers
Drug: Amiodarone

First Posted Date: 2010-09-10

Last Posted Date: 2012-01-20

Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Target Recruit Count: 199

Registration Number: NCT01198275

Locations: 🇮🇹
Arrhytmias and Heart failure Unit-Spedali Civili Hospital, Brescia, Italy

Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation

Phase 3

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: Amiodarone

First Posted Date: 2010-08-02

Last Posted Date: 2014-08-21

Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Target Recruit Count: 176

Registration Number: NCT01173809

Locations: 🇺🇸
St.David's Medical Center, Austin, Texas, United States

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

Phase 3

Terminated

Conditions: Tachycardia, Ventricular
Defibrillators, Implantable

Interventions: Procedure: Ablation
Drug: Amiodarone

First Posted Date: 2010-04-01

Last Posted Date: 2020-01-29

Lead Sponsor: Population Health Research Institute

Target Recruit Count: 12

Registration Number: NCT01097330

Locations: 🇺🇸
Texas Cardiac Arrhythmia Research Foundation, Austin, Texas, United States
🇨🇦
Southlake Regional Health Centre, Newmarket, Ontario, Canada
🇨🇦
Hamilton Health Sciences, Hamilton, Ontario, Canada

and more 8 locations

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

Phase 2

Completed

Conditions: Arrhythmia Prophylaxis
Ventricular Arrhythmia

Interventions: Drug: Celivarone
Drug: Amiodarone
Drug: Matching placebo

First Posted Date: 2009-10-12

Last Posted Date: 2016-05-30

Lead Sponsor: Sanofi

Target Recruit Count: 486

Registration Number: NCT00993382

Locations: 🇺🇸
Investigational Site Number 840045, Chicago, Illinois, United States
🇩🇪
Investigational Site Number 276005, Bad Neustadt, Germany
🇦🇺
Investigational Site Number 036003, Woolloongabba, Australia

and more 148 locations