A clinical trial to study the effective dose and safety of Bosentan (two times a day vs. three times a day) in children with pulmonary arterial hypertensio
- Conditions
- Health Condition 1: null- Pulmonary arterial hypertension
- Registration Number
- CTRI/2011/06/001843
- Lead Sponsor
- ACTELION Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
1.PAH diagnosis confirmed with RHC:
Idiopathic or heritable PAH, or
Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery)
2.WHO functional class I, II or III.
3.Male or female ≥ 2 years and 12 years of age (maximum age at randomization is 11.5 years).
4.Body weight ≥ 3.5 kg.
5.Peripheral oxygen saturation (SpO2) ≥ 88% (at rest, on room air).
6.Baseline PAH therapy (calcium channel blocker, bosentan, intravenous or inhaled prostanoid, oral PDE-5 inhibitor) if present, has to be stable for at least 3 months prior to screening.
During the study, all background treatments should remain stable.
7.Signed informed consent by the parents or legal representatives.
1. PAH etiologies other than listed above
2. Non-stable disease status, e.g., history of recurrent (near-) syncope or signs and symptoms of noncompensated right heart failure.
3. Need or plan to wean patient from intravenous
epoprostenol or intravenous or inhaled iloprost.
4. Systolic blood pressure 80% of the lower limit of normal range.
5. AST and/or ALT values 1.5 times the upper limit of normal range.
6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
7. Hemoglobin and/or hematocrit levels 75% of the lower limit of normal range.
8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet.
9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization,whichever is the longest:
- Glibenclamide (glyburide)
- Cyclosporin A
- Sirolimus
- Tacrolimus
- Fluconazole
- Rifampicin (rifampin)
- Ritonavir
- Co-administration of CYP2C9 inhibitors
(e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g.,amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole)
- Endothelin receptor antagonists (ERAs) other than bosentan
10. Treatment with another investigational drug within 1 month prior to randomization or planned treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method