13 results
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 proposed study is designed to test the hypothesis that the combination of anticoagulants, in particular Dalteparin plus Sunitinib, can be safely administered in a phase I feasibility trial in patients with renal cell cancer in which Sunitinib…
Primary objectives:To determine the difference in effect of prophylactic daily LMWH injections with standard high risk antenatal care compared to standard high risk antenatal care only for the prevention of preeclampsia and IUGR and to assess the…
OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…
Our main objective is to determine the effect of HO-1 induction by heme arginate infusion on insulin resistance and endothelial dysfunction related to MetS. Secondary objectives are to determine the effect on adipose tissue, adiponectin plasma level…
To evaluate in detail the functionality of immune cells in the liver and blood in chronic HCV patients before, during and after treatment with telaprevir, pegylated-IFN-alfa and ribavirin.
Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…
The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…
This study involves research and the objective of this study is to investigate the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug moves through the body) of telaprevir. And to obtain additional data regarding the safety…
The primary objective of the study is to determine the rate of majorbleeding events in cancer subjects receiving extended treatment withdalteparin (> 6 months and up to 12 months) for prevention ofrecurrent symptomatic venous thromboembolism…
The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…
The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH compared with dalteparin for theprevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects…
In this study, we will investigate the influence of the amino acid L-arginine, which enhances release of nitric oxide in the body, on BAT activity and metabolism in healthy subjects with overweight. This will increase understanding on the effect of…