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CLINICAL TRIALS PROFILE FOR AMIODARONE HYDROCHLORIDE

Clinical Trials for Amiodarone Hydrochloride

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00000464	Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000464	Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)	Completed	University of Washington	Phase 3	To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000531	Antiarrhythmics Versus Implantable Defibrillators (AVID)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	To evaluate if use of an implantable cardiac defibrillator (ICD) results in reduction in total mortality, when compared with conventional pharmacological therapy, in patients resuscitated from sudden cardiac death who are otherwise at very high risk of mortality from arrhythmic causes.
NCT00000556	Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.
NCT00000609	Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	To compare conventional treatment of congestive heart failure (CHF) with two experimental interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).
NCT00006330	Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn	Completed	National Center for Research Resources (NCRR)	N/A	Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To date, little information is known about the effect of hawthorn when taken with other drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects will be recruited by advertisement. The design of the study will include a 10-day and a three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover. There will be a three-week washout period in between treatment phases. On day 10 (phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration. Additionally, the subjects will be assessed for any clinical toxicities or adverse events. The significance of this study is to provide the clinician with information regarding the safe use of digoxin in combination with the herbal supplement, hawthorn.
NCT00007605	Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm	Completed	VA Office of Research and Development	Phase 3	Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.
Trial ID	Title	Status	Sponsor	Phase	Summary