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

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ClinicalTrials.gov Identifier: NCT00448214
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: YM150 Drug: warfarin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : March 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Low dose
Drug: YM150
Oral
Experimental: 2
Middle dose
Drug: YM150
Oral
Experimental: 3
High dose
Drug: YM150
Oral
Active Comparator: 4 Drug: warfarin
Oral



Primary Outcome Measures :
  1. All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)" [ Time Frame: 16 Weeks ]

Secondary Outcome Measures :
  1. Incidence of symptomatic stroke [ Time Frame: 16 Weeks ]
  2. Incidence of transient ischemic attack (TIA) [ Time Frame: 16 Weeks ]
  3. Incidence of systemic thromboembolic event [ Time Frame: 16 Weeks ]
  4. Incidence of the bleeding rates [ Time Frame: 16 Weeks ]
  5. Other safety assessments [ Time Frame: 16 Weeks ]
  6. PK, PD variables [ Time Frame: 16 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448214


Locations
Australia
Launceston, Australia
Hong Kong
Pok Fu Lam, Hong Kong
Sha Tin, Hong Kong
Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyusyu, Japan
Shikoku, Japan
Tohoku, Japan
Korea, Republic of
Seoul, Korea, Republic of
Malaysia
kuala Lumpur, Malaysia
New Zealand
Hastings, New Zealand
Singapore
Singapore, Singapore
South Africa
Bloemfontein, South Africa
Taiwan
Taipei, Taiwan
Thailand
Bangkok, Thailand
Chiang Mai, Thailand
Nakhon Ratchasima, Thailand
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00448214     History of Changes
Other Study ID Numbers: 150-CL-030
First Posted: March 16, 2007    Key Record Dates
Last Update Posted: December 19, 2011
Last Verified: December 2011

Keywords provided by Astellas Pharma Inc:
Factor Xa inhibitor
Atrial fibrillation
Stroke
Ischemic attack
thromboembolism
Prevention and control

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Darexaban
Warfarin
Factor Xa Inhibitors
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action