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

This study has been completed.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
First received: July 18, 2007
Last updated: October 26, 2010
Last verified: October 2010

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.

Condition Intervention Phase
Atrial Fibrillation
Drug: Edoxaban (DU-176b)
Drug: warfarin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Clinical Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    clinically relevant bleeding adverse events

  • Laboratory marked abnormalities [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    liver enzyme and/or bilirubin abnormalities

Secondary Outcome Measures:
  • Incidence of major adverse cardiovascular events (MACE) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    stroke, SEE, myocardial infarction (MI), cardiovascular death, and hospitalization for any cardiac condition

  • Effects on biomarkers of thrombus formation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Absolute values at each evaluation and changes from baseline in D-dimer, Prothrombin Fragments 1 and 2 (F1 and F2)

  • Pharmacokinetics of DU-176b including known metabolites in subjects receiving DU-176b [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Absolute values at each evaluation and changes from baseline in plasma DU-176b and known metabolite concentrations

  • Effects on pharmacodynamic biomarkers in subjects receiving DU-176b [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Absolute values at each evaluation and changes from baseline in biomarkers (anti-Factor Xa [FXa] activity, endogenous FXa activity, PT, INR, prothrombinase induced clotting time [PiCT], thrombin generation using the calibrated automated thrombogram [CAT-TG]

Enrollment: 1146
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DU-176b 30mg tablet once daily
Drug: Edoxaban (DU-176b)
30mg tablet once daily
Experimental: 2
DU-176b 60mg once daily
Drug: Edoxaban (DU-176b)
60mg tablet once daily
Experimental: 3
DU-176b 30mg b.i.d.
Drug: Edoxaban (DU-176b)
30mg tablet two times a day
Experimental: 4
DU-176b 60mg tablets two times a day
Drug: Edoxaban (DU-176b)
60mg tablet two times a day
Active Comparator: 5
warfarin tablets
Drug: warfarin
warfarin tablets


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects with mitral valve disease or previous valvular heart surgery
  2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
  3. Known or suspected hereditary or acquired bleeding or coagulation disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504556

  Show 91 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Anne MacDonald, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00504556     History of Changes
Other Study ID Numbers: DU176b-PRT018
Study First Received: July 18, 2007
Last Updated: October 26, 2010
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Belarus: Ministry of Health
Bosnia: Central Ethics Committee, Ministarstvo Zdravstva (Ministry of Health)
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Latvia: State Agency of Medicines
Mexico: Federal Commission for Protection Against Health Risks
Moldova: Central Ethics Committee, Drug Agency of Ministry of Health
Russia: Ethics Committee
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health. Central Ethics Committee

Keywords provided by Daiichi Sankyo Inc.:
Venous Thromboembolism
Prevention of Blood Clots
Atrial Fibrillation
Non-valvular atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014