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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01707394




Registration number
NCT01707394
Ethics application status
Date submitted
12/10/2012
Date registered
16/10/2012
Date last updated
22/03/2021

Titles & IDs
Public title
Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
Scientific title
Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder
Secondary ID [1] 0 0
2012-001581-15
Secondary ID [2] 0 0
CV185-118
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Experimental: Group 1: Apixaban (low dose) -

Experimental: Group 2A: Apixaban (low dose) -

Experimental: Group 2B: Apixaban (low dose) -

Experimental: Group 3: Apixaban (low dose) -

Experimental: Group 4: Apixaban (low dose) -

Experimental: Group 5: Apixaban (low dose) -

Experimental: Group 2A (higher dose): Apixaban (low dose) -


Treatment: Drugs: Apixaban
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
Timepoint [1] 0 0
Up to 26 hours, post dose (from Day 1 to Day 2)
Primary outcome [2] 0 0
Maximum estimated plasma concentration (Cmax) of Apixaban
Timepoint [2] 0 0
Up to 26 hours, post dose (from Day 1 to Day 2)
Primary outcome [3] 0 0
Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban
Timepoint [3] 0 0
Up to 26 hours, post dose (from Day 1 to Day 2)
Secondary outcome [1] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 30 Days after last dosing
Secondary outcome [2] 0 0
Number of participants with Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 30 Days after last dosing
Secondary outcome [3] 0 0
Change from baseline in Vital Signs of body temperature
Timepoint [3] 0 0
Up to 30 Days after last dosing
Secondary outcome [4] 0 0
Change from baseline in Vital Signs of respiratory rate
Timepoint [4] 0 0
Up to 30 Days after last dosing
Secondary outcome [5] 0 0
Change from baseline in Vital Signs of blood pressure
Timepoint [5] 0 0
Up to 30 Days after last dosing
Secondary outcome [6] 0 0
Change from baseline in Vital Signs of heart rate
Timepoint [6] 0 0
Up to 30 Days after last dosing
Secondary outcome [7] 0 0
Number of participants with abnormalities in Physical Examinations
Timepoint [7] 0 0
Up to 30 Days after last dosing
Secondary outcome [8] 0 0
Change from baseline in Clinical Laboratory Tests of blood
Timepoint [8] 0 0
Up to 30 Days after last dosing
Secondary outcome [9] 0 0
Change from baseline in Clinical Laboratory Tests of blood serum
Timepoint [9] 0 0
Up to 30 Days after last dosing
Secondary outcome [10] 0 0
Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment
Timepoint [10] 0 0
Up to 30 Days after last dosing
Secondary outcome [11] 0 0
Change from baseline in International Normalized Ratio (INR) clotting activity during treatment
Timepoint [11] 0 0
Up to 30 Days after last dosing
Secondary outcome [12] 0 0
Change from baseline in Prothrombin Time (PT) clotting activity during treatment
Timepoint [12] 0 0
Up to 30 Days after last dosing
Secondary outcome [13] 0 0
Change from baseline in Clinical Laboratory Tests of urine
Timepoint [13] 0 0
Up to 30 Days after last dosing
Secondary outcome [14] 0 0
Pharmacodynamics will be analyzed using anti-Factor Xa activity
Timepoint [14] 0 0
Up to 26 hours, post dose (from Day 1 to Day 2)

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com



* Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder
* Neonates = 34 weeks gestational or = 37 weeks post conceptual age (corrected gestational age) to <18 years of age

* Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age
* Neonates: defined as newly born (within 4 weeks)
* Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system
Minimum age
1 Day
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug
* Active bleeding or high risk of bleeding
* Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube [NG tube] or gastronomy tube [G-tube])

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
10/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Israel
State/province [16] 0 0
Ramat Gan
Country [17] 0 0
Mexico
State/province [17] 0 0
Distrito Federal
Country [18] 0 0
Mexico
State/province [18] 0 0
Jalisco
Country [19] 0 0
Mexico
State/province [19] 0 0
Nuevo Leon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis
Trial website
https://clinicaltrials.gov/study/NCT01707394
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/study/NCT01707394