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 - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00504556

Purpose

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 Thromboembolism	Drug: Edoxaban (DU-176b) Drug: warfarin	Phase II

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

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

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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.:

Anti-coagulant
Non-valvular
Venous Thromboembolism

Prevention of Blood Clots
Atrial Fibrillation
Non-valvular atrial fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis

Vascular Diseases
Thrombosis
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012