Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01083732
First received: March 8, 2010
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data


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
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 Successive Groups of Children Aged 2 Years to Less Than 12 Years Followed by 1 Year to Less Than 2 Years

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

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: 30 days ] [ Designated as safety issue: No ]
  • Changes in laboratory and clinical parameters [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dabigatran etexilate
treatment with dabigatran oral solution as a single dose
Drug: dabigatran etexilate
Experimental dose chosen based on age and weight

Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. males or females 1 to less than 12 years of age
  2. objective diagnosis of primary VTE
  3. completion of planned treatment course with LMWH or OAC for primary VTE
  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
  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: NCT01083732

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

Locations
Austria
1160.89.43001 Boehringer Ingelheim Investigational Site Recruiting
Wien, Austria
Belgium
1160.89.32003 Boehringer Ingelheim Investigational Site Recruiting
Brussel, Belgium
Canada, Alberta
1160.89.00002 Boehringer Ingelheim Investigational Site Recruiting
Edmonton, Alberta, Canada
Canada, Ontario
1160.89.00001 Boehringer Ingelheim Investigational Site Recruiting
Ottawa, Ontario, Canada
1160.89.00005 Boehringer Ingelheim Investigational Site Recruiting
Toronto, Ontario, Canada
France
1160.89.33002 Boehringer Ingelheim Investigational Site Recruiting
Marseille, France
1160.89.33001 Boehringer Ingelheim Investigational Site Recruiting
Paris, France
Italy
1160.89.39001 Boehringer Ingelheim Investigational Site Recruiting
Roma, Italy
Latvia
1160.89.37101 Boehringer Ingelheim Investigational Site Recruiting
Riga, Latvia
Lithuania
1160.89.37001 Boehringer Ingelheim Investigational Site Recruiting
Vilnius, Lithuania
Netherlands
1160.89.31003 Boehringer Ingelheim Investigational Site Recruiting
Nijmegen, Netherlands
1160.89.31004 Boehringer Ingelheim Investigational Site Recruiting
Utrecht, Netherlands
Norway
1160.89.47001 Boehringer Ingelheim Investigational Site Recruiting
Bergen, Norway
Spain
1160.89.34001 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1160.89.34002 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
Switzerland
1160.89.41001 Boehringer Ingelheim Investigational Site Recruiting
Zürich, Switzerland
Thailand
1160.89.66001 Boehringer Ingelheim Investigational Site Recruiting
Bangkok, Thailand
1160.89.66002 Boehringer Ingelheim Investigational Site Recruiting
Bangkok, Thailand
1160.89.66003 Boehringer Ingelheim Investigational Site Recruiting
Khon Kaen, Thailand
Ukraine
1160.89.38001 Boehringer Ingelheim Investigational Site Recruiting
Dnipropetrovsk, Ukraine
1160.89.38002 Boehringer Ingelheim Investigational Site Recruiting
Lugansk, Ukraine
1160.89.38003 Boehringer Ingelheim Investigational Site Recruiting
Vinnytsya, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01083732     History of Changes
Other Study ID Numbers: 1160.89, 2009-013618-29
Study First Received: March 8, 2010
Last Updated: November 5, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: National Institute of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014