13 results
Primairy objective:- Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks, measured by laser Doppler imaging, in SSc subjects with an early or active SSc pattern, measured with nailfold capillaroscopy (NFM), with…
Identify congenital heart disease patients with exercise-induced pulmonary arterial hypertension. Analyze changes in pulmonary arterial pressures at peak exercise in patients with exercise induced pulmonary arterial hypertension before and after…
To evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension (PAH).
The primary objectives are:- To demonstrate the relationship of blood flow in the hands and the extent of digital ulcera in patients with systemic scleroderma;- Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks…
To investigate whether an endothelin-1 receptor antagonist improves exercise capacity (peak V*O2) in adults with CHD or with mitral valve lesions who undergo cardiac surgery.
To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…
The objective of this trial is to demonstrate that bosentan delays disease worsening or death in patients with IPF.
To assess long-term safety and tolerability of bosentan in patients with IPF.
· To determine therapeutic efficacy of Tracleer in patients with active Behcet disease. Furthermore:· To study cytokine and immunological patterns and ET-1levels in those patients.
The study will compare the overall survival (OS) between the MABp1 treated and placebo arms. Secondary endpoints will include change in lean body mass from screening to the cycle 5 assessment and change in quality of life.
Primary Objective:The primary objective is to evaluate the effects of various doses of BMS-986231 compared to placebo on clinically relevant hypotension (defined by SBP < 90 mm Hg or symptoms of hypotension)Secondary Objectives:* Assess the…
To investigate whether bosentan added to usual care improves arterial stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium and large arteries corrected for blood pressure changes in patients with SSc with digital…
Primary* Evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo. Secondary* Evaluate the effects of BMS-986231 on the left ventricular (LV)…