Bosentan in Children With Pulmonary Arterial Hypertension (FUTURE-1)
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|ClinicalTrials.gov Identifier: NCT00319267|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Bosentan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Multicenter Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Pediatric Formulation of Bosentan in Children With Idiopathic or Familial Pulmonary Arterial Hypertension|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||February 2007|
The initial dose of bosentan was 2 mg/kg b.i.d. for 4 weeks. After 4 weeks, the initial dose was up-titrated to the maintenance dose of 4 mg/kg b.i.d. up to the end of the study treatment at Week 12. If the maintenance dose was not well tolerated, the dose could be down-titrated to the initial dose.
Pediatric oral formulation of bosentan, i.e., 32 mg dispersible and breakable tablets
- Area under the plasma concentration-time curve during a dose interval (AUCt) for bosentan [ Time Frame: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose ]AUCt was assessed at steady state (i.e., after at least 2 weeks of treatment with a same dose of the study drug) over 12 hours .
- Maximum plasma concentration (Cmax) of bosentan and its metabolites [ Time Frame: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose ]Maximum observed plasma concentration for bosentan and its metabolites was directly derived from their respective plasma concentration-time curves.
- Time to reach the maximum plasma concentration (tmax) of bosentan and its metabolites [ Time Frame: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose ]
- Area under the plasma concentration-time curve during a dose interval (AUCt) for the metabolites of bosentan [ Time Frame: At pre-dose and 0.5h, 1h, 3h, 7.5h, and 12h post-dose ]AUCt was assessed at steady state (i.e., after at least 2 weeks of treatment with a same dose of the study drug) over 12 hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319267
|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|
|Hopital Antoine Beclere|
|Clamart, France, 92140|
|Paris, France, 75743|
|CHE de Toulouse Hopital d'Enfants|
|Policlinico S. Orsola-Malpighi|
|Bologna, Italy, 40138|
|Beatrix Children's Hospital|
|Hopital des Enfants|
|The Institute of Child Health|
|London, United Kingdom|