Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age

October 23, 2015 updated by: Boehringer Ingelheim

Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89

Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States
        • 1160.145.00010 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States
        • 1160.145.00009 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • 1160.145.00008 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 1160.145.00012 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Newark, New Jersey, United States
        • 1160.145.00007 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • 1160.145.0006 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, United States
        • 1160.145.00001 Boehringer Ingelheim Investigational Site
    • Washington
      • Spokane, Washington, United States
        • 1160.145.00011 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. males or females 1 to less than 2 years of age
  2. objective diagnosis of primary venous thromboembolism
  3. completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism
  4. written informed consent by parent (legal guardian) and patient assent (if applicable)

Exclusion criteria:

  1. weight less than 9 kg
  2. conditions associated with increased risk of bleeding
  3. patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dabigatran etexilate
single dose treatment with dabigatran oral solution
Drug: dabigatran etexilate
age & weight adjusted equivalent of adult dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ecarin clotting time (ECT)
Time Frame: one day
one day
Factor IIa inhibition
Time Frame: one day
one day
Incidence of all bleeding events
Time Frame: 30 days
30 days
Incidence of all adverse events
Time Frame: 30 days
30 days
Plasma concentrations of total dabigatran
Time Frame: one day
one day
Plasma concentrations of free dabigatran
Time Frame: one day
one day
Plasma concentrations of BIBR 1048 BS (Base)
Time Frame: one day
one day
Plasma concentrations of BIBR 951 BS
Time Frame: one day
one day
Plasma concentrations of BIBR 1087 SE (Acid)
Time Frame: one day
one day
Activated prothrombin time (aPTT)
Time Frame: one day
one day

Secondary Outcome Measures

Outcome Measure
Time Frame
Global assessment of tolerability will be summarized across all patients in the treated set
Time Frame: 30 days
30 days
Patient assessment of taste will be summarized across all patients in the treated set
Time Frame: one day
one day
Changes in laboratory and clinical parameters
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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