NCT01707394 is a Phase 1 clinical trial of Apixaban in Thromboembolism, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT01707394?

NCT01707394 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT01707394?

Interventions in NCT01707394: Apixaban.

What condition does NCT01707394 study?

NCT01707394 studies Thromboembolism.

Is NCT01707394 still recruiting?

NCT01707394 is currently completed. Last updated 22 March 2021.

Last reviewed 2021-03-22 · How we verify

NCT01707394

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

Completed Phase 1 Last updated 22 March 2021

What this trial tests

Phase 1 trial testing Apixaban in Thromboembolism in 49 participants. Completed in 30 June 2020.

Timeline

10 January 2013

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	49
Start date	10 January 2013
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	27 locations across Israel, Mexico, Canada, Australia, United States

Drugs / interventions tested

Apixaban (apixaban) — full drug profile →

Conditions studied

Thromboembolism — all drugs for Thromboembolism →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 1 Day to 18, any sex, with Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.
Byon W, Garonzik S, Boyd RA, Frost CE. · · 2019 · cited 215× · PMID 31089975 · DOI 10.1007/s40262-019-00775-z
Evidence Gaps in the Era of Non-Vitamin K Oral Anticoagulants.
Aronis KN, Hylek EM. · · 2018 · cited 27× · PMID 29374049 · DOI 10.1161/jaha.117.007338
Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder.
Merali SJ, Byon W, Patel YT, Elsrougy A, et al · · 2023 · cited 6× · PMID 36861188 · DOI 10.1002/psp4.12935
Unmet Needs in Anticoagulant Therapy: Potential Role of Rivaroxaban.
Eikelboom JW, Connolly SJ. · · 2015 · cited 2× · PMID 28197239 · DOI 10.14740/cr413w
Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase.
Jarugula P, Ajavon-Hartmann T, Obianom O, Ludwig E, et al · · 2025 · cited 1× · PMID 40302153 · DOI 10.1002/cpt.3616
Adverse Events of Factor Xa Inhibitors in Pediatric Patients: A Meta-analysis and Pharmacovigilance Study.
Chong S, Sun L, Mu G, Hua M, et al · · 2025 · PMID 39826085 · DOI 10.1007/s40272-024-00665-3

Verify or expand the search:

Other trials of Apixaban

Trials testing the same drug.

NCT06953726 — Comparing the Safety and Efficacy of Apixaban and Rivaroxaban · Phase 4 · not yet recruiting
NCT07493304 — Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Canc · Phase 3 · not yet recruiting
NCT07521332 — Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis · Phase 4 · recruiting
NCT07160686 — Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment · Phase 3 · not yet recruiting
NCT07404345 — Low-Dose Apixaban Added to Standard Heparin Lock Versus Heparin Lock Alone to Prevent Tunneled Hemodialysis Catheters Dy · Phase 4 · not yet recruiting

Other recruiting trials for Thromboembolism

Currently open trials in the same condition.

NCT06657924 — Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery · Phase 2 · recruiting
NCT06442267 — Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support · Phase 4 · recruiting
NCT06443905 — Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients · active not recruiting
NCT05301348 — In Vivo Detection of Circulating Clots in Patients With Thromboembolism · NA · recruiting
NCT06627933 — Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01707394 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 22 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01707394.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing