10 results
• To assess the long-term bronchodilation of aclidinium/formoterol FDCs compared to individual components and placebo, when administered twice daily via inhalation to COPD patients.• To assess the benefits of aclidinium/formoterol FDCs in COPD…
To determine whether a dosing algorithm containing genetic information increases the time within therapeutic INR range during anticoagulation therapy with phenprocoumon compared to a dosing regimen that does not contain this genetic information.…
Objectives:To collect data on effect size for, and determine the feasibility of, a full scale multicentre RCT(Randomized Controlled Trial) that1. compares the efficacy and safety of NOACs with VKA treatment according to Dutchstandards, in VKA-…
Section 7 of the protocol:7. TRIAL OBJECTIVES AND PURPOSE* To assess the long term bronchodilator efficacy of Aclidinium bromide/Formoterol fumarate, administered twice a day, compared to Salmeterol/Fluticasone propionate (SeretideTM AccuhalerTM) in…
The primary efficacy objective is to evaluate whether LMWH is superior to VKAs in the long-term treatment of symptomatic VTE in cancer patients who completed 6 to 12 months of anticoagulant treatment. Two aspects are important: the efficacy with…
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…
The main objective is to collect data on effect size for, and determine the feasibility of, a full scale RCT to assess the effect of dosing per 0.5 mg acenocoumarol on quality of anticoagulation, treatment satisfaction, and medication errors.
5.1 Primary ObjectiveTo confirm the efficacy of glepaglutide in reducing PS volume in SBS patients.5.2 Secondary ObjectivesTo evaluate the efficacy of glepaglutide on other efficacy endpoints in patients with SBS.To evaluate the safety and…
* To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and…
- To compare the pharmacokinetics (PK) of glepaglutide after a single subcutaneous (SC) administration by vial/syringe and by autoinjector.- To evaluate the safety and tolerability of glepaglutide following SC dosing in healthy subjects.