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

Atrial Fibrillation Clinical Trial

— OPAL-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938730
• Other study ID #: 150-CL-021
• Secondary ID: 2007-001150-87
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2009
• Last updated: January 18, 2011
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Agency for Health and Food SafetyBulgaria: Bulgarian Drug AgencyChina: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIndia: Central Drugs Standard Control OrganizationIndonesia: National Agency of Drug and Food ControlIsrael: Ministry of HealthJapan: Pharmaceuticals and Medical Devices AgencyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthMalaysia: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Philippines: Bureau of Food and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Spanish Agency of MedicinesThailand: Ministry of Public HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1280
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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,  Austria,  Bulgaria,  Czech Republic,  Estonia,  France,  Germany,  Hungary,  India,  Israel,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  Philippines,  Poland,  Russian Federation,  Slovakia,  South Africa,  Spain,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major and clinically relevant non-major bleeding events		Double-blind treatment period (variable, up to 16 months)	Yes
Secondary	Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths		Double-blind treatment period (variable, up to 16 months)	No
Secondary	Incidence of bleeding events		Double-blind treatment period (variable, up to 16 months)	Yes
Secondary	Assessment of other safety variables		Double blind treatment period (variable, up to 16 months)	No
Secondary	Assessment of PK/PD variables		Double-blind treatment period (up to week 12)	No
Secondary	Patient Reported Outcomes		Double-blind treatment period (up to week 24)	No