Skip to main content
OpenTrials
Completed

NCT Number: NCT00806624

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hong Kong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DU-176b tablets

Drug

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

warfarin tablets

Drug

Warfarin tablets taken once daily for up to 3 months

Primary outcomes

  1. Incidence of All Bleeding

    Time frame: 6 months

    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.

Secondary outcomes

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

    Time frame: 6 months

  2. Evaluation of Effects on Biomarkers of Thrombus Formation

    Time frame: 6 months

  3. Evaluation of Plasma Concentration of DU-176

    Time frame: 6 months

  4. Evaluation of Effects on Pharmacodynamic Biomarkers

    Time frame: 6 months

  5. Evaluation of All Clinical and Laboratory Safety Data.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 11, 2008
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.