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

Stroke Clinical Trial

Official title:

A Phase 2, Randomized, Parallel Group, Multi-Center, Multi-National Study for the Evaluation of Safety and Efficacy of Two Fixed Dosages of DU-176b in Subjects With Non-Valvular Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806624
• Other study ID #: DU176b-C-J226
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Est. completion date: November 2009

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: November 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Drug:
• DU-176b tablets
DU-176b tablets taken once daily for up to 3 months
• DU-176b tablets
DU-176b tablets taken once daily for up to 3 months
• Warfarin tablets
Warfarin tablets taken once daily for up to 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

China,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition		6 months
Secondary	Evaluation of Effects on Biomarkers of Thrombus Formation		6 months
Secondary	Evaluation of Plasma Concentration of DU-176		6 months
Secondary	Evaluation of Effects on Pharmacodynamic Biomarkers		6 months
Secondary	Evaluation of All Clinical and Laboratory Safety Data.		6 months