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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01773174
First received: January 18, 2013
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Venous Thromboembolism
Drug: dabigatran etexilate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Ecarin clotting time (ECT) [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Factor IIa inhibition [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Incidence of all bleeding events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of all adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Plasma concentrations of total dabigatran [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Plasma concentrations of free dabigatran [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Plasma concentrations of BIBR 1048 BS (Base) [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Plasma concentrations of BIBR 951 BS [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Plasma concentrations of BIBR 1087 SE (Acid) [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Activated prothrombin time (aPTT) [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global assessment of tolerability will be summarized across all patients in the treated set [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Patient assessment of taste will be summarized across all patients in the treated set [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Changes in laboratory and clinical parameters [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dabigatran etexilate
single dose treatment with dabigatran oral solution
Drug: dabigatran etexilate
age & weight adjusted equivalent of adult dose

  Eligibility

Ages Eligible for Study:   1 Year to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 10 kg
  2. conditions associated with increased risk of bleeding
  3. patients who have any condition that would not allow safe participation in study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773174

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, New Jersey
1160.145.00007 Boehringer Ingelheim Investigational Site Not yet recruiting
Newark, New Jersey, United States
United States, Pennsylvania
1160.145.0006 Boehringer Ingelheim Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States
United States, Texas
1160.145.00001 Boehringer Ingelheim Investigational Site Recruiting
Houston, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01773174     History of Changes
Other Study ID Numbers: 1160.145
Study First Received: January 18, 2013
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014