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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR DIGOXIN PEDIATRIC

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Clinical Trials for Digoxin Pediatric

Trial ID Title Status Sponsor Phase Summary
NCT00000476 Digitalis Investigation Group (DIG) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.
NCT00000547 Enalapril After Anthracycline Cardiotoxicity Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine if the chronic administration of enalapril, an inhibitor of angiotensin converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology patients who have received anthracyclines, and who are not currently on digoxin, diuretics, or vasodilators for heart failure.
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.
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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Digoxin Pediatric

Condition Name

Condition Name for Digoxin Pediatric
Intervention Trials
Healthy 28
Atrial Fibrillation 10
Heart Failure 9
Healthy Volunteers 7
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Condition MeSH

Condition MeSH for Digoxin Pediatric
Intervention Trials
Heart Failure 18
Atrial Fibrillation 15
Heart Diseases 5
Diabetes Mellitus 4
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Clinical Trial Locations for Digoxin Pediatric

Trials by Country

Trials by Country for Digoxin Pediatric
Location Trials
United States 130
Germany 18
Canada 14
United Kingdom 9
France 6
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Trials by US State

Trials by US State for Digoxin Pediatric
Location Trials
Texas 17
California 9
Florida 9
Ohio 7
New York 7
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Clinical Trial Progress for Digoxin Pediatric

Clinical Trial Phase

Clinical Trial Phase for Digoxin Pediatric
Clinical Trial Phase Trials
Phase 4 18
Phase 3 13
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Digoxin Pediatric
Clinical Trial Phase Trials
Completed 96
Recruiting 20
Not yet recruiting 11
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Clinical Trial Sponsors for Digoxin Pediatric

Sponsor Name

Sponsor Name for Digoxin Pediatric
Sponsor Trials
Boehringer Ingelheim 12
Bristol-Myers Squibb 7
AstraZeneca 6
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Sponsor Type

Sponsor Type for Digoxin Pediatric
Sponsor Trials
Other 110
Industry 86
NIH 11
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