13 results
Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).
Primary objective* To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) at rest in comparison with placebo in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).Secondary objectives* To…
To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).
Objective: To test the hypothesis that clozapine treatment compared to risperidone treatment is associated with a significant reduction in subjective craving and in a lower activity of the different functional craving pathways and their associated…
To assess the long-term safety and tolerability of macitentan in patients with symptomatic pulmonary arterial hypertension (PAH).
Primary objectiveTo compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-…
The primary objective of the study is to evaluate the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic PAH.Secondary objectivesTo evaluate the safety and tolerability of macitentan in patients with…
The proposed study aims to examine the antidepressant efficacy of oral S-ketamine augmentation in patients with TRD treated with regular antidepressants in a double-blind randomised controlled trial. Secondary questions involve the effects of oral S…
Evaluation of the feasibility of a trial on the efficacy of oral esketamine for the treatment of depression and/or demoralization in patients with advanced cancer who receive palliative care.
PRIMARY OBJECTIVE: -To assess the antibody response after mRNA (Pfizer, Moderna) SARS-CoV-2 vaccination in children with cancerSECONDARY OBJECTIVES:To assess in children with cancer after SARS-CoV 2 vaccination:- durability of the antibody response…
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary…
To assess the antibody response after SARS-CoV-2 vaccination in people >=16 years and children with Down Syndrome. Part 2To assess the antibody response after a third SARS-CoV-2 vaccination in adults and children with Down Syndrome and to…
To determine whether VSA treatment with the novel ERA macitentan reduces the frequency and severity of anginal complaints among patients with clinically defined VSA. To determine side effects related to treatment with macitentan in patients with VSA…