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

This study is currently recruiting participants.
Verified June 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01083732
First received: March 8, 2010
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Safety: incidence of all bleeding events [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Safety: incidence of all adverse events [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • PK parameters: plasma concentrations [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • PD parameter: local and central measurement of Thrombin time [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: laboratory and clinical parameters [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Safety: clinical outcomes (e.g., recurrent thrombosis, Venous thromboembolism) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • PD parameter: local measurement of Activated Partial Thromboplastin Time [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Safety: Assessment of tolerability and taste [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (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
  Contacts and Locations
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 Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01083732     History of Changes
Other Study ID Numbers: 1160.89, 2009-013618-29
Study First Received: March 8, 2010
Last Updated: June 12, 2013
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
Spain:
Switzerland: Swissmedic
Thailand:
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on June 17, 2013