Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

Completed · Phase 3 · Has a placebo group

Conditions studied: Stroke, Atrial Fibrillation, Embolism

In brief

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, \& Warfarin. The expected duration of the study is 24 months.

Key facts

Study ID

NCT00781391

Run by

Daiichi Sankyo

People needed

21105

Starts

2008-11-01

Expected to finish

2013-05-01

Last updated by the study team

2019-03-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 years of age or older; male or female.
• Able to provide written informed consent.
• History of documented AF within the prior 12 months
• A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

You may not qualify if…

• Transient atrial fibrillation secondary to other reversible disorders
• Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
• Subjects with any contraindication for anticoagulant agents;
• Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
• Females of childbearing potential including the following:
• Females with a history of tubal-ligation
• Females less than 2 years post-menopausal

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Gilbert, Arizona, United States
• Study site — Glendale, Arizona, United States
• Study site — Lake Havasu City, Arizona, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Harrisburg, Arkansas, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Alhambra, California, United States
• Study site — Anaheim, California, United States
• Study site — Burbank, California, United States
• Study site — Chula Vista, California, United States
• Study site — Encinitas, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Glendale, California, United States
• Study site — Healdsburg, California, United States
• Study site — Lakewood, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Alamitos, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Banos, California, United States
• Study site — Mather, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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