DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation

NCT00806624 | Completed Phase 2 Results DMC

• 1 other identifier: DU176b-C-J226
• Study Type: interventional
• Target: 234
• Locations: 4 countries
• Sites: 4

Brief Summary

This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence of All Bleeding

  Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF.

  6 months

Secondary Outcomes (5)

• Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition

  6 months

• Evaluation of Effects on Biomarkers of Thrombus Formation

  6 months

• Evaluation of Plasma Concentration of DU-176

  6 months

• Evaluation of Effects on Pharmacodynamic Biomarkers

  6 months

• Evaluation of All Clinical and Laboratory Safety Data.

  6 months

Study Arms (3)

2

EXPERIMENTAL

DU-176b tablets: high-dose

Drug: DU-176b tablets

3

ACTIVE COMPARATOR

Warfarin tablets

Drug: Warfarin tablets

1

EXPERIMENTAL

DU-176b tablets: low-dose

Drug: DU-176b tablets

Interventions

DU-176b tablets DRUG

DU-176b tablets taken once daily for up to 3 months

1

Warfarin tablets DRUG

Warfarin tablets taken once daily for up to 3 months

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 18 to 80 years of age
• Non-valvular AF supported by abnormal ECG documented for two times (interval of more than 1 week) within 6 months prior to randomization.
• CHADS2 Score of at least 1.

You may not qualify if:

• Subjects with mitral valve disease
• Subjects with previous valvular heart surgery
• Contraindication for anticoagulants
• Conditions associated with high risk of bleeding
• Acute coronary syndromes (ACS), percutaneous coronary intervention (PCI), MI, stroke, transient ischemic attack (TIA) or coronary artery/cardiac/other major surgery within the previous 30 days
• Active infective endocarditis or life-expectancy \< 12 months

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Hong Kong, China

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

edoxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Atsushi Nonogaki, Manager
• Organization: Daiichi Sankyo.,LTD

nonogaki.atsushi.zz@daiichisankyo.co.jp

81-80-3029-7553

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2009
• Last Updated: February 26, 2019
• Results First Posted: January 26, 2015

Record last verified: 2015-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

CN (1); SG (1); KR (1); TW (1)