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.

Sponsor:

Information provided by:

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00504556

First received: July 18, 2007

Last updated: October 26, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 18, 2007
Last Updated Date	October 26, 2010
Start Date ^ICMJE	June 2007
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 2, 2010)	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
Original Primary Outcome Measures ^ICMJE (submitted: July 18, 2007)	The primary objective of this study is to evaluate safety of fixed doses DU-176b compared to warfarin in subjects with atrial fibrillation.
Change History	Complete list of historical versions of study NCT00504556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2010)	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]
Original Secondary Outcome Measures ^ICMJE (submitted: July 18, 2007)	The secondary objectives are evaluate fixed dose regimens of DU176b with respect to major cardiac adverse events, and pharmacokinetic and pharmacodynamic properties of DU-176b.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Atrial Fibrillation Thromboembolism
Intervention ^ICMJE	Drug: Edoxaban (DU-176b) 30mg tablet once daily Drug: Edoxaban (DU-176b) 60mg tablet once daily Drug: Edoxaban (DU-176b) 30mg tablet two times a day Drug: Edoxaban (DU-176b) 60mg tablet two times a day Drug: warfarin warfarin tablets
Study Arm (s)	Experimental: 1 DU-176b 30mg tablet once daily Intervention: Drug: Edoxaban (DU-176b) Experimental: 2 DU-176b 60mg once daily Intervention: Drug: Edoxaban (DU-176b) Experimental: 3 DU-176b 30mg b.i.d. Intervention: Drug: Edoxaban (DU-176b) Experimental: 4 DU-176b 60mg tablets two times a day Intervention: Drug: Edoxaban (DU-176b) Active Comparator: 5 warfarin tablets Intervention: Drug: warfarin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1146
Completion Date	June 2008
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belarus, Belgium, Bosnia and Herzegovina, Canada, Chile, Latvia, Mexico, Moldova, Republic of, Russian Federation, Slovakia, Ukraine

Administrative Information
NCT Number ^ICMJE	NCT00504556
Other Study ID Numbers ^ICMJE	DU176b-PRT018
Has Data Monitoring Committee	Yes
Responsible Party	Anne MacDonald, Daiichi Sankyo
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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