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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
448
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00448214