14 results
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…
The purpose of the study is to investigate to what extent FE 201836 is tolerated. It will also be investigated how quickly and to what extent FE 201836 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
The purpose of the study is to investigate to what extent FE 202217 is tolerated. It will also be investigated how quickly and to what extent FE 202217 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).
Primary objectives:1) Describe the PD effects on plasma ACTH and serum cortisol upon 100 µg hCRH injection with or without a preceding injection of 10 µg dDAVP 2 hours earlier and study the PK-PD relationship (*Block B*). In particular, the outcome…
This proposal centers on hormone-behavior dynamics in paternal caregiving, with the goal of gaining a better understanding of the development of human paternal caregiving. There is limited information on the hormonal basis of caregiving patterns in…
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-…
In a clinical trial it will be investigated to what extent combination therapy with LEF and HCQ will 1) inhibit disease activity, in particular improvement of ESSDAI and dryness and 2) inhibit activity of (autoreactive) B-cells, T-cells and pDCs. In…
1) To evaluate the safety and tolerability of MLT*s npMNAs2) To evaluate the pharmacokinetics of intradermal desmopressin administration via MLT*s npMNAs
A multicenter randomized placebo controlled treatment study of leflunomide in polymyalgia rheumatica
To investigate whether the use of leflunomide can prevent relapses during glucocorticoid tapering in patients with polymyalgia rheumatica.
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…
Primary objective:To evaluate the efficacy of each active treatment combination (hydroxychloroquine + leflunomide and hydroxychloroquine + mycophenolate mofetil) based on proportion of responder patients according to preliminary STAR at week 24.…
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…
To assess clinical efficacy and safety of Leflunomide/Hydroxychloroquine in pSS patients in a phase IIb placebo-controlled randomized clinical trial at 24 weeks, followed by a single-arm crossover and an open extension (total duration of 48 weeks)…