ong-term, open-label, multicenter extension study of bosentan in patients with pulmonary hypertension associated with sickle cell disease completing a double-blind ASSET study (AC-052-368 or AC-052-369) - ASSET-3
- Conditions
- Pulmonary Hypertension (PH) associated with sickle cell diseaseMedDRA version: 8.1Level: LLTClassification code 10037400Term: Pulmonary hypertension
- Registration Number
- EUCTR2006-000374-75-GB
- Lead Sponsor
- Actelion Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 316
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
All patients (Groups A and B):
1.Any major protocol violation in the preceding double-blind ASSET study
2.Hemoglobin concentration < 6.0 g/dL
3.Pregnancy or breast-feeding
Group B only:
4.Acute liver disease
5.Newly diagnosed cirrhosis or portal hypertension
6.ALT = 3 times the upper limit of normal (ULN) and/or albumin > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method