15 results
To study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers 7 days post-administration.
(1) To assess the effect of ARA 290 on the ventilatory response to hypoxia (and compare the effects to Epo); (2) To assess the effect of ARA 290 on the gradient over the tricuspid valve during hypoxia (and compare the effects to Epo); (3) To assess…
This is an open label proof of principle study, in 14 patients. The objective of the study is to test the efficacy and safety of ARA 290 in patients with active rheumatoid arthritis. To assess the efficacy, disease activity is examined based on…
To measure the PK of ARA290 when given in de SQ form
To assess the analgesic effect of ARA290 in chronic pain patients
The aim of the CO-PRINCE study is to establish the efficacy and safety of long-term antibiotic prophylaxis with co-trimoxazolein children with recurrent upper and/or lower respiratory tract infections (including ear-nose-throat (ENT)).
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-…
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…
In this study we will assess the effect of ARA290 on nerve damage by taking 4 skin bipsies during treatment.
To measure the plasma conc. of ARA 290 in healthy volunteers
To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).
ARA290 is a new drug against neuropathic pain and was succesfully tested in previous studies on patients with neuropathic pain due to diabetes and sarcoidosis. The current study involves sarcoidosis patients with pain due to neuropathy. The purpose…
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).
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 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…