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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:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00504556
First received: July 18, 2007
Last updated: March 12, 2015
Last verified: March 2015
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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:
- Adjudicated Incidence of Bleeding Events [ Time Frame: 3 months ]Adjudicated Incidence of Bleeding Events during treatment period
- Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA) [ Time Frame: 3 months ]liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities
Secondary Outcome Measures:
- Incidence of Major Adverse Cardiac Events MACE) [ Time Frame: 3 months ]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
- Effects on Biomarker D-dimer [ Time Frame: 3 months ]Mean (SD) change from baseline in D-dimer
- Effects on Biomarker Prothrombin Fragments [ Time Frame: 3 months ]Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)
- Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b [ Time Frame: 3 months ]Median (min, max) values of Cmin,ss; Cmax,ss
- Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b [ Time Frame: 3 months ]Median (min, max) values of AUCss
- Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b [ Time Frame: Day 28 ]Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.
- Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b [ Time Frame: Day 28 ]Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.
- Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b [ Time Frame: Day 28 ]
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.
- Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b [ Time Frame: Day 28 ]Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.
- Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b [ Time Frame: Day 28 ]Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504556
Show 91 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504556
Show 91 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
More Information
| Responsible Party: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00504556 History of Changes |
| Other Study ID Numbers: |
DU176b-PRT018 |
| Study First Received: | July 18, 2007 |
| Results First Received: | February 5, 2015 |
| Last Updated: | March 12, 2015 |
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 Edoxaban |
Warfarin Anticoagulants Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 21, 2017