A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00938730

Purpose

The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: YM150 Drug: Warfarin	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study To Investigate the Safety and Tolerability of YM150 in Subjects With Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability With Warfarin

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 YM150 Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence of major and clinically relevant non-major bleeding events [ Time Frame: Double-blind treatment period (variable, up to 16 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths [ Time Frame: Double-blind treatment period (variable, up to 16 months) ] [ Designated as safety issue: No ]
Incidence of bleeding events [ Time Frame: Double-blind treatment period (variable, up to 16 months) ] [ Designated as safety issue: Yes ]
Assessment of other safety variables [ Time Frame: Double blind treatment period (variable, up to 16 months) ] [ Designated as safety issue: No ]
Assessment of PK/PD variables [ Time Frame: Double-blind treatment period (up to week 12) ] [ Designated as safety issue: No ]
Patient Reported Outcomes [ Time Frame: Double-blind treatment period (up to week 24) ] [ Designated as safety issue: No ]

Estimated Enrollment:	1280
Study Start Date:	June 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. YM150, Dose W, twice daily: Experimental	Drug: YM150 oral
2. YM150, Dose X, once daily: Experimental	Drug: YM150 oral
3. YM150, Dose X, twice daily: Experimental	Drug: YM150 oral
4. YM150, Dose Y once daily: Experimental	Drug: YM150 oral
5. YM150, Dose Y twice daily: Experimental	Drug: YM150 oral
6. YM150, Dose Z, once daily: Experimental	Drug: YM150 oral
7. Warfarin: Active Comparator	Drug: Warfarin oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit

Exclusion Criteria:

Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA)
Subject has active bleeding or any condition associated with increased risk of bleeding
Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis)
Subject has an indication for warfarin other than AF (including planned cardioversion)
Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening
Subject has a diagnosis of left ventricular aneurysm or atrial myxoma
Subject requires use of prohibited previous and concomitant medication (i.e., thrombolytics [such as tissue Plasminogen Activator (tPA), streptokinase], antiplatelet agents [such as cilostazol, clopidogrel, ticlopidine, dipyridamole], anticoagulants [such as vitamin K antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors] and chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs] or acetylsalicylic acid use of >100 mg/day). (see Section 5.1.3 and Appendix 1 for details)
Subject has active infective endocarditis
Subject is planned for invasive procedures with potential for bleeding
Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
Subject has participated in any YM150 clinical trials

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938730

Contacts

Contact: Astellas Pharma Europe BV Medical Clinical Development Department

+ 31 (0)71 54 55878

Show 189 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Use Central Contact

Astellas Pharma Europe BV

More Information

No publications provided

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	150-CL-021, EudraCT number: 2007-001150-87
Study First Received:	July 1, 2009
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00938730 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Agency for Health and Food Safety; Bulgaria: Bulgarian Drug Agency; China: State Food and Drug Administration; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; Indonesia: National Agency of Drug and Food Control; Israel: Ministry of Health; Japan: Pharmaceuticals and Medical Devices Agency; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Malaysia: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Philippines: Bureau of Food and Drugs; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; South Korea: Korea Food and Drug Administration (KFDA); Spain: Spanish Agency of Medicines; Thailand: Ministry of Public Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ukraine: Ministry of Health

Keywords provided by Astellas Pharma Inc:

Nonvalvular Atrial Fibrillation (NVAF)
Factor Xa Inhibitor
Stroke
Thromboembolism
Transient Ischemic attack

Anticoagulants
Prevention
YM150
Warfarin

Study placed in the following topic categories:

Signs and Symptoms
Ischemic Attack, Transient
Anticoagulants
Heart Diseases
Cerebral Infarction
Stroke

Warfarin
Ischemia
Atrial Fibrillation
Antithrombin III
Thromboembolism
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Heart Diseases
Therapeutic Uses
Hematologic Agents

Cardiovascular Diseases
Warfarin
Atrial Fibrillation
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 11, 2009