Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
Hypothesis:
Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of
episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12
months by more than 25% compared to standard medication without angiotensin II type 1
receptor.
A total of 422 subjects will be included in the two study groups. The treatment arm will
receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12
months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes
of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are
allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic "recovery
medication" (amiodarone) is allowed during follow-up.
Phase:
Phase 3
Details
Lead Sponsor:
Atrial Fibrillation Network German Atrial Fibrillation Network
Collaborators:
Daiichi Sankyo Inc. Daiichi Sankyo, Inc.
Treatments:
Angiotensin II Angiotensin Receptor Antagonists Angiotensinogen Olmesartan Olmesartan Medoxomil