NCT00448214

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for phase_2 atrial-fibrillation

Timeline
Completed

Started Mar 2007

Geographic Reach
10 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

1.6 years

First QC Date

March 15, 2007

Last Update Submit

December 15, 2011

Conditions

Atrial Fibrillation

Keywords

Factor Xa inhibitorAtrial fibrillationStrokeIschemic attackthromboembolismPrevention and control

Outcome Measures

Primary Outcomes (1)

  • All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"

    16 Weeks

Secondary Outcomes (6)

  • Incidence of symptomatic stroke

    16 Weeks

  • Incidence of transient ischemic attack (TIA)

    16 Weeks

  • Incidence of systemic thromboembolic event

    16 Weeks

  • Incidence of the bleeding rates

    16 Weeks

  • Other safety assessments

    16 Weeks

  • +1 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

Low dose

Drug: YM150

2

EXPERIMENTAL

Middle dose

Drug: YM150

3

EXPERIMENTAL

High dose

Drug: YM150

4

ACTIVE COMPARATOR
Drug: warfarin

Interventions

YM150DRUG

Oral

123
warfarinDRUG

Oral

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Launceston, Australia

Location

Unknown Facility

Pok Fu Lam, Hong Kong

Location

Unknown Facility

Shatin, Hong Kong

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Hastings, New Zealand

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Bloemfontein, South Africa

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

Unknown Facility

Nakhon Ratchasima, Thailand

Location

MeSH Terms

Conditions

Atrial FibrillationStrokeThromboembolism

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 16, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 19, 2011

Record last verified: 2011-12

Locations

AU(1)ZA(1)HK(2)NZ(1)TW(1)TH(3)MY(1)JP(6)KR(1)SG(1)