Phase 2
N=234
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
Atrial Fibrillation · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00806624 ↗Enrolled (actual)
234
Serious AEs
7.7%
Results posted
Jan 2015
Primary outcome: Primary: Incidence of All Bleeding — 20.3; 23.8; 29.3 percentage of subjects with bleeds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DU-176b tablets (Drug); Warfarin tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of All Bleeding |
20.3; 23.8; 29.3 | — |
| SECONDARY Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition |
— | — |
| SECONDARY Evaluation of Effects on Biomarkers of Thrombus Formation |
— | — |
| SECONDARY Evaluation of Plasma Concentration of DU-176 |
— | — |
| SECONDARY Evaluation of Effects on Pharmacodynamic Biomarkers |
— | — |
| SECONDARY Evaluation of All Clinical and Laboratory Safety Data. |
— | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00806624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.