13 results
To demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS
Primary: To determine whether ofatumumab 3, 30 or 60 milligrams (mg) given subcutaneously (SQ), reduces the cumulative number of new T1 GdE brain lesions over a period of 12 weeks, as compared with placebo.Secondary: Cumulative number of new T1 GdE…
The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.
The aim of this trial is to test in a first clinical study the above mentioned hypothesis that BAY63-2521 can at least partially correct deltaF508-CFTR function. Therefore, we plan to include patients with Cystic Fibrosis, who are homozygous for the…
The primary objective of this study is to : Assess the hemodynamic profile of Riociguat in patients with symptomatic pulmonary hypertension associated with left ventricular systolic dysfunction The secondary objectives of this study are to : -…
BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in patients with inoperable…
BAY 63 2521 is a direct stimulator of the soluble Guanylate Cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially Pulmonary Hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in the treatment of…
BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the long-term safety and tolerability of BAY 63 2521 in the treatment…
The primary objective is to evaluate progression free survival (PFS) of ofatumumab maintenance treatment versus no further treatment after remission induction in subjects with relapsed CLL.Secondary objectives are to evaluate clinical benefit,…
Primary: To evaluate the efficacy and safety of HuMax-CD20 in patients with B-cell Chronic Lymphocytic Leukemia (B-CLL) who have failed fludarabine and alemtuzumabSecondary: To determine the host immune response to HuMax-CD20To determine the…
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…
Objectives of the study are to assess safety, tolerability and clinical effects of riociguat and provide access to inoperable patients for a condition (CTEPH) with unmet medical need.
The objective of this study is to assess the performance of the Masimo O3 regional oximeter on somatic tissue oxygenation, under controlled hypoxia. Somatic rSO2 values will be compared with combined arterial and venous blood gas measurements from…