117 results
The primary objective of the study is to evaluate the safety and tolerability of single-dose IV infusion of BIIB033 administered to healthy adult volunteers.Secondary objectives of this study are:* assess the single dose PK profile of BIIB033 *…
In this study we will assess the effects of exenatide on cardiac metabolism and function in patients with T2DM and CHF. We will address the following hypothesis: exenatide improves global cardiac function in CHF patients with T2DM, by favorable…
Main objectiveTo determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with CHC.Secondary objectivesTo assess the pharmacokinetics (PK) of multiple dosing of miravirsen administered subcutaneously to subjects…
• To evaluate the safety and efficacy of multiple doses of XPF-001 (400 mg bid) for relief of pain in patients with IEM.• To evaluate the efficacy of multiple doses of XPF-001 (400 mg bid) for relief of vasomotor signs in patient with IEM.• To…
Overarching Aim: to detail the (mechanisms underlying the) actions of GLP-1RA and DPP-4i on the cardiovascular, renal and gastrointestinal system patients with T2DM. For the sake of clarity, we divide the study objectives into 3 parts:Primary…
The primary objective of this study is to assess the hemostatic efficacy and safety of rVWF with or without ADVATE in subjects (* 18 years) diagnosed with hereditary severe VWD undergoing major and minor elective surgical procedures.
To evaluate the efficacy and safety of eASCs compared to placebo for the treatment of complex fistulas in Crohn*s disease over a 24- and 104-week period.
The primary objective of this study is to:* Evaluate the effect of GS-6615 on exercise capacity, as measured by Peak VO2 achieved during cardiopulmonary exercise testing (CPET), in subjects with symptomatic hypertrophiccardiomyopathy (HCM).The…
The objective of the present phase 2 trial is to evaluate the safety, pharmacodynamics (effect on HPA axis and calcium metabolism) and pharmacokinetics of LEO 90100 in adolescent subjects with plaque psoriasis. Subjects will be treated once daily…
The primary objective of EXSCEL will be to evaluate the effect of Bydueron, used in addition to the current usual care for glycemic control, on major macrovascular events when administered to patients with type 2 diabetes.
The objective of the present study is to assess the effect of HTL0009936 on cognitive performance in elderly subjects with below average cognitive function. The oral pharmacokinetics of HTL0009936 shows a significant degree of variability between…
The primary objective of the study is to determine the MTD (Maximally Tolerated Dose) of SGN-40 from among three possible dose levels when combined with a standard dose of bortezomib and to determine the safety and adverse event profile for…
The primary objectives of the study are:- to establish the optimal dose of the combination for second-line therapy with NAMI-A and Gemcitabine (Phase I part)- to assess the response rate according to RECIST criteria (Phase II part) in advanced NSCLC…
Overall objective:The overall objective is to test the hypothesis that GLP-1 receptor activation of CNS reward and satiety circuits occurs, in the context of food(-related) stimuli, and that this effect is altered in individuals with obesity and…
The primary objective of this study is to evaluate overall survival (OS) in the intent-to-treat (ITT) subject population defined by this protocol.Key secondary objectives are to evaluate OS in the epidermal growth factor receptor (EGFR) wild type…
The primary objective of this study is to compare overall survival (OS) in patients with metastatic colorectal carcinoma (CRC) when treated with FOLFIRI in combination with placebo versus FOLFIRI in combination with ramucirumab DP.Secondary…
The primary objective of this phase III study in subjects with metastatic and/or unresectable GIST who have progressed after therapy with at least imatinib and sunitinib is to compare the treatment groups in terms of Progression-Free Survival (PFS…
This is a placebo- and active-controlled dose-range-finding study which isalso designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twicedaily versus placebo as an adjunct therapy to L-dopa when administered to subjectswith moderate…
The primary objective of this study is to evaluate the tumor response of stable disease (SD), partial response, or complete response at at 12 weeks (according to RECIST 1.1 criteria) in two separate cohorts representing molecularly distinct subsets…
The primary objective is to demonstrate that glycemic control, as measured by hemoglobin A1c(HbA1c) at 52 weeks for LY2605541 is noninferior to insulin glargine, when each is combined with preprandial insulin lispro, in patients with type 1 diabetes…