15 results
The primary objective of the study is to demonstrate the superiority of the combination BAY 60 4552 / vardenafil over vardenafil alone in the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors.The…
zie study protocol
Secondary objectives are to evaluate the effect of intravenous FCM compared to pla¬cebo on:1. Evolution from baseline of cardiac function parameters as assessed by 2D Echo/Doppler cardiography 4, 12 and 24 weeks after start of study treatment.2.…
The objective of this pilot study is to investigate wether:- Increased Hb levels prior to the operation can prevent blood transfusions preoperative, blood transfusions have a negative effect on the survival of cancer patients- Treatment with…
In this research we will investigate if i.v. iron therapy can become a method of blood saving therapy for orthopedic surgery and can replace erytropoietin.
Primary objective of the study is• To investigate efficacy and safety of different oraldoses of BAY94-8862 given once daily over 90 daysThe secondary objectives are:•To assess the effects of these doses on a compositeendpoint of death from any cause…
To evaluate the effects of intravenous iron suppletion in iron deficient PAH patients.Amendment: to compare exercise capacity and isolated muscle strength in IPAH patients and healthy controls
To examine if intravenous administration of iron ismore efficacious than oral iron in improvement offitness scores, iron status and reduction of fatigue
To study the effects of FCM on exercise tolerance, haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, microbiota, the immune system, the incidence of infections, allograft failure and mortality in…
Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…
That patients who have had clinical response or clinical remission after use with Risankizumab can continue using Risankizumab. Also long term safety of Risankizumab will be assessed in patients who were diagnosed with moderate to severe Crohn'…
Primary Objective(s)* To evaluate, relative to placebo, the effect of intravenous (IV) FCM on repeated heart failure (HF) hospitalisations and cardiovascular (CV) death.Secondary Objective(s)* To evaluate, relative to placebo, the effect of IV FCM…
Primary: To characterize the safety and tolerability of LXH254 single agent and to identify recommended doses for future studies in adult patients with advanced solid tumors harboring MAPK pathway alterations.To characterize the safety and…
To evaluate if hepcidin levels can predict response to iron therapy with either ferrous fumarate, ferric maltol, and intravenous iron in patients with IBD.
Asses whether, in patients with heart failure with preserved ejection fraction and iron deficiency, ferric carboxymaltose improves leftventricular diastolic function and skeletal muscle function by improving energy metabolism