33 results
The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…
Primary Objective:The objective of this pilot study is to determine whether the observed AP pharmacokinetic profiles in plasma of CABG patients in the APPIRED study can be confirmed in the CABG patients under a non-aprotinin regime.
The purpose of the multicenter, randomized, open-label, parallel-group study EFC11628 is to compare the efficacy and safety of HOE901-U300 with that of Lantus®, both given once-daily s.c. as part of a basal-bolus insulin regimen in patients with…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
Primary objective(s)• To evaluate the efficacy of blinatumomab to induce complete MRD responseKey secondary objective for patients with Ph-negative ALL • To evaluate the effect of blinatumomab on hematological relapseOther Secondary objectives• To…
Primary* To determine the maximum tolerated dose or recommended phase 2 dose of oral BYL719 as single agent and in combination with fulvestrantSecondary* To assess the overall safety and tolerability of BYL719 as single agent and in combination with…
To compare to control (Group A) (peginterferon alfa-2a [Peg IFN-*-2a] and ribavirin [RBV] for 48 weeks) the proportion of subjects who achieve sustained viral response (SVR, undetectable HCV RNA 24 weeks after completion of treatment) when given…
To provide access to a telaprevir-based treatment to subjects of the Control Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate response to treatment (according to treatment stopping rules). Safety, tolerability, and HCV…
A pilot study to:1. assess the urodynamic changes induced by 100mg MR formulationof UK-369,003 vs. placebo in men with LUTS;2. Assess the safety and tolerability of UK-369,003 in men with LUTS
Primary1. To assess the major (complete/partial) cytogenetic response (MCyR) rateSecondary1. To determine the duration of MCyR2. To determine the complete hematologic response (CHR) rate3. To determine the complete cytogenetic response (CCyR) rate4…
Objective(s): Part 1: To determine the safety, tolerability, pharmacokinetics (PK), and efficacy of single ascending doses of OPC-108459 following one 10-minute constant rate infusion in adultsubjects diagnosed with paroxysmal or persistent AF. Part…
Primary objective:To evaluate the effect of each of 2 doses of AK001 separately in combination with an INS versus the INS alone on the reduction in size of nasal polyps as evaluated by the change from Baseline to Week 12 after the start of treatment…
The primary objective of this study is to evaluate and compare the plasma PK parameters of TETA and its two metabolites (MAT and DAT) after two dose levels of Syprine® capsules and TETA 4HCL tablets in adult healthy male and female volunteers.The…
Tiotropium is available in the pharmacy as solution for inhalation (daily dose of 5 mcg) and as inhalation powder (daily dose of 18 mcg). The objective of the present study is to compare three doses of tiotropum solution for inhalation (daily dose…
Primary Objective• To determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumor necrosis factor alpha (TNFa) antagonist therapy (TNFa subpopulation)Secondary…
The goal of this study is to assess the safety and immunogenicity of the seasonal and pandemic inactivated whole virion influenza vaccines produced with the production process set up by the NVI for technology transfer (proof of principle).
Primary objective(s)Phase Ib:-Define the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab in patients with advanced or metastatic HER2-positive breast cancers.Phase II:-Evaluate…
Primary To determine the MTD of LDK378 (oral administration) as a single agent Secondary* Safety and tolerability of LDK378* To characterize single and multiple-dose PK of LDK378.* To assess preliminary anti-tumor activity of LDK378