Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00319020
First received: April 26, 2006
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

This is a multicenter, multinational, open label, non-comparative, phase III extension study to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension.


Condition Intervention Phase
Pulmonary Hypertension
Drug: bosentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed AC-052-365 (Future 1)

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Treatment-emergent adverse events [ Time Frame: up to 24 hours after discontinuation ] [ Designated as safety issue: Yes ]
  • Adverse events leading to premature discontinuation of study drug [ Time Frame: discontinuation of study ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: up to 28 days after permanent discontinuation of study drug ] [ Designated as safety issue: Yes ]
  • Changes from Baseline in vital signs, body weight, and height [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
  • Treatment-emergent marked laboratory abnormalities [ Time Frame: Discontinuation of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline from FUTURE 1 of WHO functional class, quality of life questionnaire, Global Clinical Impression Scale according to parents/legal guardians and physician [ Time Frame: Study End or premature study drug discontinuation ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2005
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
32 mg breakable tablets
Drug: bosentan
32 mg breakable tablets 4 mg maintenance dose
Other Name: Tracleer

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent by the parents or the legal representatives.
  • Patients who completed the FUTURE 1 study.
  • Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of FUTURE 1.
  • Males or females >= 2 and < 12 years of age at enrollment in FUTURE 2 (this study). Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.

Exclusion Criteria:

  • Intolerance to bosentan despite dose reductions.
  • Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy.
  • Pregnancy or breast-feeding.
  • Known hypersensitivity to bosentan or any of the excipients.
  • Premature and permanent study drug discontinuation during FUTURE 1.
  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: NCT00319020

Locations
United States, Colorado
The Children's Hospital Cardiac Care Center
Denver, Colorado, United States, 80218
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
France
Hopital Antoine Beclere
Clamart, France, 92140
Hopital Necker
Paris, France, 75743
CHE de Toulouse Hopital d'Enfants
Toulouse, France
Germany
Deutsches Herzzentrum
Augustenburger, Germany
Universitats Kinderklinik
Giessen, Germany
Italy
Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Netherlands
Beatrix Children's Hospital
Groningen, Netherlands
Switzerland
Hopital des Enfants
Geneva, Switzerland
United Kingdom
The Institute of Child Health
London, United Kingdom
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00319020     History of Changes
Other Study ID Numbers: AC-052-367, FUTURE 2
Study First Received: April 26, 2006
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
pulmonary arterial hypertension
bosentan
children
FUTURE 1

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014