Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Warfarin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448214
• Other study ID #: 150-CL-030
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2007
• Last updated: December 15, 2011
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareKorea: Food and Drug AdministrationTaiwan: Department of HealthHong Kong: Department of HealthSingapore: Clinical Trials & Epidemiology Research Unit (CTERU)Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Health Research CouncilMalaysia: Ministry of HealthSouth Africa: Department of Health
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects are eligible for the study if all of the following apply:

• Subject has paroxysmal permanent or persistent NVAF

• Subject has INR of 2.0 or below and an aPTT = 1.5 times the upper limit of normal at the baseline visit.

• Legal minimum age requirement (country-specific).

• Written informed consent has been obtained.

Exclusion Criteria:

• History of heart valve disorders

• History of rheumatic fever.

• History of stroke and/or systemic embolism (including TIA).

• History of Acute Coronary Syndrome (ACS).

• Indication for warfarin other than NVAF.

• Known hemorrhagic disorder and/or coagulation disorder.

• Active bleeding or any condition associated with increased risk of bleeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• YM150
Oral
• warfarin
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Australia,  Hong Kong,  Japan,  Korea, Republic of,  Malaysia,  New Zealand,  Singapore,  South Africa,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"		16 Weeks	Yes
Secondary	Incidence of symptomatic stroke		16 Weeks	Yes
Secondary	Incidence of transient ischemic attack (TIA)		16 Weeks	Yes
Secondary	Incidence of systemic thromboembolic event		16 Weeks	Yes
Secondary	Incidence of the bleeding rates		16 Weeks	Yes
Secondary	Other safety assessments		16 Weeks	No
Secondary	PK, PD variables		16 Weeks	No