DU-176b Phase 2 Dose Finding Study in Subjects With Non-Valvular Atrial Fibrillation - Full Text View

Sponsored by:	Daiichi Sankyo Co., Ltd.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00806624

Purpose

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).

Condition	Intervention	Phase
Atrial Fibrillation Stroke	Drug: DU-176b tablets Drug: Warfarin tablets	Phase II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Evaluation of effects on biomarkers of thrombus formation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Evaluation of plasma concentration of DU-176 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Evaluation of effects on pharmacodynamic biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Evaluation of all clinical and laboratory safety data. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	235
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental DU-176b tablets: high-dose	Drug: DU-176b tablets DU-176b tablets taken once daily for up to 3 months
3: Active Comparator Warfarin tablets	Drug: Warfarin tablets Warfarin tablets taken once daily for up to 3 months
1: Experimental DU-176b tablets: low-dose	Drug: DU-176b tablets DU-176b tablets taken once daily for up to 3 months

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806624

Locations

China

Hong-Kong, China
Korea, Republic of

Seoul, Korea, Republic of
Singapore

Singapore, Singapore
Taiwan

Taipei, Taiwan

Sponsors and Collaborators

Daiichi Sankyo Co., Ltd.

More Information

Responsible Party:	Daiichi Sankyo Co., Ltd. ( Associate Manager )
Study ID Numbers:	DU176b-C-J226
Study First Received:	December 10, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00806624
Health Authority:	Taiwan: Department of Health; Korea: Food and Drug Administration; Hong Kong: Department of Health; Singapore: Health Sciences Authority

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Cerebral Infarction
Stroke

Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Therapeutic Uses

Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009