A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-Valvular Atrial Fibrillation - Full Text View

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00504556

Purpose

This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

Condition	Intervention	Phase
Atrial Fibrillation Thromboembolism	Drug: Du-176b Drug: DU-176b Drug: warfarin	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title:	A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation

Resource links provided by NLM:

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

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

The primary objective of this study is to evaluate safety of fixed doses of DU-176b compared to warfarin in subjects with atrial fibrillation. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary objectives are to evaluate fixed dose regimens of DU-176b with respect to major cardiac adverse events, and pharmacokinetic and pharmacodynamic properties of DU-176b. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DU-176b 30mg tablet once daily	Drug: Du-176b 30mg tablet once daily
2: Experimental DU-176b 60mg once daily	Drug: DU-176b 60mg tablet once daily
3: Experimental DU-176b 30mg b.i.d.	Drug: DU-176b 30mg tablet two times a day
4: Experimental DU-176b 60mg tablets two times a day	Drug: DU-176b 60mg tablet two times a day
5: Active Comparator warfarin tablets	Drug: warfarin warfarin tablets

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, 18 to 80 years old.
Able to provide written informed consent.
Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2

Exclusion Criteria:

Subjects with mitral valve disease or previous valvular heart surgery
Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
Known or suspected hereditary or acquired bleeding or coagulation disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504556

Show 91 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided

Responsible Party:	Daiichi Sankyo ( Anne MacDonald )
Study ID Numbers:	DU176b-PRT018
Study First Received:	July 18, 2007
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00504556 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Belarus: Ministry of Health; Bosnia: Central Ethics Committee, Ministarstvo Zdravstva (Ministry of Health); Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Latvia: State Agency of Medicines; Mexico: Federal Commission for Protection Against Health Risks; Moldova: Central Ethics Committee, Drug Agency of Ministry of Health; Russia: Ethics Committee; Slovakia: State Institute for Drug Control; Ukraine: Ministry of Health. Central Ethics Committee

Keywords provided by Daiichi Sankyo Inc.:

Anti-coagulant
Non-valvular
Venous Thromboembolism

Prevention of Blood Clots
Atrial Fibrillation
Non-valvular atrial fibrillation

Study placed in the following topic categories:

Embolism and Thrombosis
Anticoagulants
Heart Diseases
Embolism
Vascular Diseases
Warfarin

Atrial Fibrillation
Venous Thromboembolism
Thrombosis
Thromboembolism
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Heart Diseases
Anticoagulants
Hematologic Agents
Vascular Diseases
Warfarin
Pharmacologic Actions
Thromboembolism

Thrombosis
Embolism and Thrombosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 11, 2009