17 results
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…
Primary Objective: To compare the pharmacokinetics of the needlefree system with the Apo-go penject. Secondary objectives: - To assess the clinical effect of Apo-go vs. de needlefree system, using an "automated tap score" and a "Timed…
· 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.
To assess long-term safety and tolerability of bosentan in patients with IPF.
The objective of this trial is to demonstrate that bosentan delays disease worsening or death in patients with IPF.
Main objectives Part 1• To evaluate the safety and tolerability of a single oral dose of HTL0018318, administered at one of at least three ascending dose levels (maximum of 8 ascending dose levels), in healthy younger adult male subjects.• To…
1. To evaluate the safety and tolerability of ascending multiple oral doses of HTL18318 in healthy adult male and female subjects.2. To evaluate the pharmacokinetics of ascending multiple oral doses of HTL18318 in healthy adult male and female…
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…
To investigate the efficacy of continuous subcutaneous apomorphine infusion compared to placebo in PD patients with visual hallucinations.
The primary objective of this pilot study is to determine the effectiveness of four treatment options for local skin reactions induced by continuous subcutaneous apomorphine infusion, as compared to no treatment.The primary endpoint is the measured…
* To evaluate the safety and tolerability of adding multiple oral doses of HTL0018318 in elderly volunteers taking donepezil at steady state.* To compare the pharmacokinetic profiles of HTL0018318 and donepezil when given alone and in combination at…
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…
The primary objective of the study as a whole (part A-C) is to assess the PK and safety of buccal apomorphine relative to registered apomorphine formulations (subcutaneous, sublingual). Secondary objectives are the characterization of the PK-AE…