10 results
The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects <60 kg with stable coronary artery disease (CAD) versus the…
The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects >=75 years of age with stable coronary artery disease (CAD) versus…
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for GA at birth while confirming the dose of rhIGF 1/rhIGFBP-3 is safe and efficacious.
: The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects >=75 years of age with stable coronary artery disease (CAD)…
The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects <60 kg with stable coronary artery disease (CAD) versus the…
During the course of the study 2 randomisation questions will be adressed. Both questions concern patients in the high risk group.Randomisation question 1: Will the addition of Doxorubicin to the first 4 standard IVA chemotherapy courses lead to a…
To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based chemotherapy treatment To assess the proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is…
Primary:* Phase I: to establish the recommended phase II dose (RP2D) of BCT-100 in children andyoung adults as assessed by dose limiting toxicity (DLT) and complete arginine depletion.* Phase II: to determine the activity of single agent BCT-100…
The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET results in improved efficacy while minimizing treatment toxicity in advanced stage HL patients treated with BV-containing regimens, BrAVD and…
The primary objective of this study is to assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the incidence of severe BPD (as defined by the modified NICHD severity grading) at 36 weeks (±3 days) PMA, or death…