Idiopathic or familial PAH
Conditions
Interventions
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: bosentan monohydrate
CAS Nu
Sponsors
Actelion Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients should start the study drug (bosentan pediatric formulation) at the 2mg/kg b.i.d whether or not they were previously treated with bosentan. Eligible patients must meet all of the following inclusion criteria during the Screening visit: · Signed informed consent by the parents or the legal representatives. · Male or female =2 and =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be included in the study if any of the following exclusion criteria are present at the Screening visit: · 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 3 times the upper limit of normal ranges. · Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C. (See Appendix 4 of the protocol). · 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint is to demonstrate that the exposure to bosentan in children with IPAH or familial PAH, using a pediatric formulation, is similar to that in adults with PAH.;Secondary Objective: The secondary objective of this study is to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population.;Primary end point(s): The main analysis of the primary endpoint is performed on the PK-evaluable set for this equivalence study. | — |
Countries
Italy, United Kingdom
Outcome results
None listed