A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation

Completed · Phase 2

Conditions studied: Atrial Fibrillation, Thromboembolism

In brief

This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

Key facts

Study ID

NCT00504556

Run by

Daiichi Sankyo

People needed

1146

Starts

2007-06-01

Expected to finish

2008-06-01

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 to 80 years old.
• Able to provide written informed consent.
• Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
• A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2

You may not qualify if…

• Subjects with mitral valve disease or previous valvular heart surgery
• Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
• Known or suspected hereditary or acquired bleeding or coagulation disorder

Where it is running

• Study site — Anaheim, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Stockton, California, United States
• Study site — Orlando, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Canton, Georgia, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Cadillac, Michigan, United States
• Study site — Kalispell, Montana, United States
• Study site — Fremont, Nebraska, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — Albany, New York, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Pottstown, Pennsylvania, United States
• Study site — Sellersville, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Bellevue, Washington, United States
• Study site — Minsk, Belarus
• Study site — Brussels, Belgium
• Study site — Genk, Belgium
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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