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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504556
• Other study ID #: DU176b-PRT018
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: June 2008

Study information

• Verified date: March 2015
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1146
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thromboembolism

Intervention

Drug:
• Edoxaban (DU-176b)
30mg tablet once daily
• Edoxaban (DU-176b)
60mg tablet once daily
• Edoxaban (DU-176b)
30mg tablet two times a day
• Edoxaban (DU-176b)
60mg tablet two times a day
• warfarin
warfarin tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Belgium,  Bosnia and Herzegovina,  Canada,  Chile,  Latvia,  Mexico,  Moldova, Republic of,  Russian Federation,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated Incidence of Bleeding Events	Adjudicated Incidence of Bleeding Events during treatment period	3 months
Primary	Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)	liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities	3 months
Secondary	Incidence of Major Adverse Cardiac Events MACE)	MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition	3 months
Secondary	Effects on Biomarker D-dimer	Mean (SD) change from baseline in D-dimer	3 months
Secondary	Effects on Biomarker Prothrombin Fragments	Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)	3 months
Secondary	Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b	Median (min, max) values of Cmin,ss; Cmax,ss	3 months
Secondary	Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b	Median (min, max) values of AUCss	3 months
Secondary	Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b	Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.	Day 28
Secondary	Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b	Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.	Day 28
Secondary	Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b	Mean (SD) change from baseline in biomarker prothrombinase induced clotting time [PICT] on Day 28, 1-3 hours post dose.; PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition.	Day 28
Secondary	Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b	Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.	Day 28
Secondary	Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b	Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.	Day 28