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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00504556
• Date of registration: 18/07/2007
• Prospective Registration: No
• Primary sponsor: Daiichi Sankyo, Inc.
• Public title: 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
• Scientific 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
• Date of first enrolment: June 2007
• Target sample size: 1146
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00504556
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Belarus, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Czech Republic, Estonia, Former Serbia and Montenegro, Germany, Latvia, Lithuania, Mexico, Moldova, Republic of, Peru, Poland, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Thromboembolism

Atrial Fibrillation

Intervention(s)

Drug: Edoxaban (DU-176b)

Drug: warfarin

Primary Outcome(s)

Adjudicated Incidence of Bleeding Events [Time Frame: 3 months]

Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA) [Time Frame: 3 months]

Secondary Outcome(s)

Effects on Biomarker Prothrombin Fragments [Time Frame: 3 months]

Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b [Time Frame: 3 months]

Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b [Time Frame: Day 28]

Effects on Biomarker D-dimer [Time Frame: 3 months]

Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b [Time Frame: Day 28]

Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b [Time Frame: 3 months]

Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b [Time Frame: Day 28]

Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b [Time Frame: Day 28]

Incidence of Major Adverse Cardiac Events MACE) [Time Frame: 3 months]

Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b [Time Frame: Day 28]

Secondary ID(s)

DU176b-PRT018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00504556