32 results
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…
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…
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…
To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…
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 primary objective of the study is to compare overall survival between the ASA404 plus docetaxel group and the placebo plus docetaxel group Key Secondary Objectives:To compare Progression-Free Survival (PFS) and the Overall…
This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and Patent Blue) in detecting…
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…
Research question:Does thin application of betamethasonvaleraat cream 0,1% on perniones lesions twice a day reduce the symptoms of patients as determined in 1st. line health care, with at least 10 mm expressed on a visual analogue scale, together…
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 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
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* 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 identify at least one New Generation Ring that shows clinically relevant treatment efficacy:• in relief of primary dysmenorrhea, as demonstrated by a statistically significantly larger reduction (as compared to baseline) in the mean menstrual…
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 Objective:To compare the efficacy of pacritinib with that of Best Available Therapy (BAT) in patients with PMF, PPV-MF, or PET-MF; the efficacy measure for this analysis is the proportion of patients achieving a * 35% reduction in spleen…
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(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…
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.