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

April 26, 2006
April 8, 2013
August 2005
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Treatment-emergent adverse events up to 24 hours after permanent discontinuation of study drug
  • Adverse events leading to premature discontinuation of study drug
  • Serious adverse events up to 28 days after permanent discontinuation of study drug
  • Changes from Baseline to Study End in vital signs, body weight, and height
  • Treatment-emergent marked laboratory abnormalities
Complete list of historical versions of study NCT00319020 on ClinicalTrials.gov Archive Site
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 ]
Change from Baseline in FUTURE 1 to Study End or Premature study drug discontinuation in WHO functional class, quality of life questionnaire, Global Clinical Impression scale according to parents/legal guardians and physician
Not Provided
Not Provided
 
Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: bosentan
32 mg breakable tablets 4 mg maintenance dose
Other Name: Tracleer
Experimental: 1
32 mg breakable tablets
Intervention: Drug: bosentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
March 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
2 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Netherlands,   Switzerland,   United Kingdom
 
NCT00319020
AC-052-367, FUTURE 2
Not Provided
Actelion
Actelion
Not Provided
Not Provided
Actelion
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP