Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

ClinicalTrials.gov ID: NCT02497716

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Official title

Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis

Brief summary

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

To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability

Study identification

NCT ID: NCT02497716
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Bayer; Industry
Enrollment: 47 participants

Conditions and interventions

Conditions

Thrombosis

Interventions

Rivaroxaban (Xarelto, BAY59-7939 Drug

Drug

Eligibility (public fields only)

Age range: 2 Months to 12 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 4, 2015 (Actual)
Primary completion: May 22, 2018 (Actual)
Completion: May 22, 2018 (Actual)
Last update posted: Apr 16, 2019

2015 – 2018

United States locations

U.S. sites: 5
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
Arkansas Children's Hospital	Little Rock	Arkansas	72202	—
Children's Hospital Oakland	Oakland	California	94609	—
Riley Hospital For Children	Indianapolis	Indiana	46202	—
Carolinas Healthcare System	Charlotte	North Carolina	28204	—
Nationwide Children's Hospital	Columbus	Ohio	43205-2696	—

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 16 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02497716, 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 Apr 16, 2019 · Synced Nov 12, 2026