Study of YM150 in Subjects with Atrial Fibrillation

• Research type

  Research Study

• Full title

  A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study to Investigate the Safety and Tolerability of YM150 in Subjects with Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability with Warfarin

• Contact name

  Gregory Y H Lip

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2007-001150-87

• ISRCTN Number

  n/a

• Research summary

  This is a multi-center study of an investigational drug, YM150, in patients with atrial fibrillation (abnormal heart rhythm). A total of 1280 patients will be involved in the study from approximately 200 centers in Europe, Australia, South Africa and Asia. Patients will be randomised (chosen by chance) into one of seven treatment groups. Six groups will have different doses of the study drug, YM150, and there will be one control group of warfarin. Patients will be in the study from 24 weeks to about 16 months depending on the time needed to complete recruitment into the study. After the screening and baseline visit, patients will have scheduled visits during the treatment period at Day 3, Weeks 1, 2, 4, 8, 12 and subsequently every 4 weeks until the last randomised patient has had 24 weeks of treatment. The treatment period will be followed by a 4-week follow-up period. During their participation in the study, patients will undergo the following assessments: vital signs (blood pressure & pulse) recorded, physical examinations including height and weight measurements, Electrocardiograms, blood samples taken for laboratory tests, and urine samples for urine tests and pregnancy tests (if applicable). Patients will also be required to complete several questionnaires throughout the study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/38

• Date of REC Opinion

  21 Apr 2009

• REC opinion

  Further Information Favourable Opinion