A Study Evaluating Safety and Tolerability of YM150 Compa... | NCT00938730

Studies
A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation

NCT00938730

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jan 20, 2011Estimated

Enrollment

1,280Actual

Phase

Phase 2

Conditions

Atrial Fibrillation

Interventions

YM150
Warfarin

Countries

Australia
Austria
Bulgaria
Czechia
Estonia
France
Germany
Hungary
India
Israel
Japan
Malaysia
Netherlands
Philippines
Poland
Russia
Slovakia
South Africa
South Korea
Spain
Thailand
Ukraine
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2007-001150-87	EudraCT Number

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jul 1, 2009

First Submission Date that Met QC Criteria

Jul 13, 2009

First Posted Date

Jul 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2011

Last Update Posted Date

Jan 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,280Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1. YM150, Dose W, twice daily	Experimental	Drug: YM150
2. YM150, Dose X, once daily	Experimental	Drug: YM150
3. YM150, Dose X, twice daily	Experimental	Drug: YM150
4. YM150, Dose Y once daily	Experimental	Drug: YM150
5. YM150, Dose Y twice daily	Experimental	Drug: YM150
6. YM150, Dose Z, once daily	Experimental	Drug: YM150
7. Warfarin	Active Comparator	Drug: Warfarin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YM150	Drug	oral	1. YM150, Dose W, twice daily 2. YM150, Dose X, once daily 3. YM150, Dose X, twice daily 4. YM150, Dose Y once daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of major and clinically relevant non-major bleeding events		Double-blind treatment period (variable, up to 16 months)

Secondary Outcomes

Measure	Description	Time Frame
Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths		Double-blind treatment period (variable, up to 16 months)
Incidence of bleeding events		Double-blind treatment period (variable, up to 16 months)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Auchenflower		4066	Australia

ID	Term
D001281	Atrial Fibrillation
D020521	Stroke
D013923	Thromboembolism
D002546	Ischemic Attack, Transient

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D016769	Embolism and Thrombosis
D002545	Brain Ischemia

ID	Term
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring