Pulmonary Hypertension (PH) associated with sickle cell disease MedDRA version: 8.1 Level: LLT Classification code 10037400 Term: Pulmonary hypertension
Conditions
Interventions
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BOSENTAN
CAS Number: 147536978
Current Sponsor code: Ro 47-0203
Concen
Sponsors
Actelion Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completion of the 16-week treatment period in the double-blind ASSET study 2. Women of childbearing potential must have a negative result on their serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination. 3. Signed written informed consent is obtained from the patient or patient’s parent/ legal representative prior to initiation of any study-related procedure. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All patients (Groups A and B): 1. Any major protocol violation in the preceding double-blind ASSET study 2. Hemoglobin concentration 20% below the lower limit of normal (LLN) 7. Newly diagnosed psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess long-term safety, tolerability and efficacy of bosentan in patients with pulmonary hypertension (PH) associated with sickle cell disease (SCD);Secondary Objective: ;Primary end point(s): No primary endpoint is defined for this open-label extension study. | — |
Countries
France, United Kingdom
Outcome results
None listed