Status:
COMPLETED
Bosentan in Children With Pulmonary Arterial Hypertension
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief Summary
The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric fo...
Eligibility Criteria
Inclusion
- Signed informed consent by the parents or the legal representatives.
- Males or females \>= 2 and \< 12 years of age.
- Idiopathic PAH or familial PAH diagnosed by right heart catheterization (Clinical classification of pulmonary hypertension, Venice 2003).
- World Health Organization (WHO) functional class II or III.
- Oxygen saturation (SpO2) \>= 88% (at rest, on room air).
- PAH treatment-naïve patients or patients already treated with either:
- Bosentan monotherapy
- Intravenous epoprostenol monotherapy
- Intravenous or inhaled iloprost monotherapy
- Combination of bosentan and intravenous epoprostenol
- Combination of bosentan and intravenous or inhaled iloprost.
- All patients should start the study drug (bosentan pediatric formulation) at 2 mg/kg twice daily (b.i.d.), whether or not they were previously treated with bosentan.
- PAH therapy stable for at least 3 months prior to Screening.
- Stable treatment with calcium channel blockers, if any, for at least 3 months prior to Screening.
- Patient's PAH condition stable for at least 3 months prior to Screening.
Exclusion
- PAH associated with conditions other than idiopathic or familial PAH.
- Non-stable patients, e.g., history (in the last 3 months prior to Screening) of recurrent syncope, or signs and symptoms of non-compensated right heart failure.
- Need or plan to wean patients from intravenous epoprostenol, or intravenous, or inhaled iloprost.
- Body weight \< 4 kg.
- Systolic blood pressure \< 80%, the lower limit of normal range, according to age and gender.
- AST and/or ALT values \> 3 times the upper limit of normal ranges.
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
- Hemoglobin and/or hematocrit levels \< 75% of the lower limit of normal ranges.
- Pregnancy.
- Known intolerance or hypersensitivity to bosentan or any of the excipients.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00319267
Start Date
May 1 2005
End Date
February 1 2007
Last Update
February 3 2025
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