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Completed Phase 1 Interventional

Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

ClinicalTrials.gov ID: NCT01145859

Public ClinicalTrials.gov record NCT01145859. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.

Study identification

NCT ID
NCT01145859
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Bayer
Industry
Enrollment
59 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Months to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2010 (Type not available)
Primary completion
Jul 2015 (Actual)
Completion
Jul 2015 (Actual)
Last update posted
Aug 6, 2015

2010 – 2015

United States locations

U.S. sites
16
U.S. states
10
U.S. cities
14
Facility City State ZIP Site status
Not listed Little Rock Arkansas 72202-3500 —
Not listed Los Angeles California 90027-6089 —
Not listed Los Angeles California 90095 —
Not listed Orange California 92868 —
Not listed Gainesville Florida 32610 —
Not listed St. Petersburg Florida 33701 —
Not listed Chicago Illinois 60611 —
Not listed Indianapolis Indiana 46202 —
Not listed Indianapolis Indiana 46260 —
Not listed Detroit Michigan 48201-2196 —
Not listed New Hyde Park New York 11040 —
Not listed Chapel Hill North Carolina 27514 —
Not listed Durham North Carolina 27710 —
Not listed Cleveland Ohio 44106-6007 —
Not listed Philadelphia Pennsylvania 19104 —
Not listed Pittsburgh Pennsylvania 15224 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01145859, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 6, 2015 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01145859 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →