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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00448214




Registration number
NCT00448214
Ethics application status
Date submitted
15/03/2007
Date registered
16/03/2007
Date last updated
19/12/2011

Titles & IDs
Public title
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
Scientific 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
Secondary ID [1] 0 0
150-CL-030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YM150
Treatment: Drugs - warfarin

Experimental: 1 - Low dose

Experimental: 2 - Middle dose

Experimental: 3 - High dose

Active Comparator: 4 -


Treatment: Drugs: YM150
Oral

Treatment: Drugs: warfarin
Oral

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
Timepoint [1] 0 0
16 Weeks
Secondary outcome [1] 0 0
Incidence of symptomatic stroke
Timepoint [1] 0 0
16 Weeks
Secondary outcome [2] 0 0
Incidence of transient ischemic attack (TIA)
Timepoint [2] 0 0
16 Weeks
Secondary outcome [3] 0 0
Incidence of systemic thromboembolic event
Timepoint [3] 0 0
16 Weeks
Secondary outcome [4] 0 0
Incidence of the bleeding rates
Timepoint [4] 0 0
16 Weeks
Secondary outcome [5] 0 0
Other safety assessments
Timepoint [5] 0 0
16 Weeks
Secondary outcome [6] 0 0
PK, PD variables
Timepoint [6] 0 0
16 Weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Launceston
Recruitment postcode(s) [1] 0 0
- Launceston
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Pok Fu Lam
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Sha Tin
Country [3] 0 0
Japan
State/province [3] 0 0
Hokkaido
Country [4] 0 0
Japan
State/province [4] 0 0
Kansai
Country [5] 0 0
Japan
State/province [5] 0 0
Kanto
Country [6] 0 0
Japan
State/province [6] 0 0
Kyusyu
Country [7] 0 0
Japan
State/province [7] 0 0
Shikoku
Country [8] 0 0
Japan
State/province [8] 0 0
Tohoku
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul
Country [10] 0 0
Malaysia
State/province [10] 0 0
kuala Lumpur
Country [11] 0 0
New Zealand
State/province [11] 0 0
Hastings
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
South Africa
State/province [13] 0 0
Bloemfontein
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei
Country [15] 0 0
Thailand
State/province [15] 0 0
Bangkok
Country [16] 0 0
Thailand
State/province [16] 0 0
Chiang Mai
Country [17] 0 0
Thailand
State/province [17] 0 0
Nakhon Ratchasima

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00448214
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Central Contact
Address 0 0
Astellas Pharma Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications