13 results
Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…
This study will investigate whether treatment with Nivolumab in combination with radiation therapy, is comparable to Temozolomide in combination with radiation therapy in patients with Unmethylated MGMT Glioblastoma. We will measure this by…
PRIMARY OBJECTIVE· 1. To study the effect of escitalopram versus placebo in the treatment of abdominal pain, in IBS patients with panic disorder.SECONDARY OBJECTIVES· 2.1. To assess the effect of escitalopram on gastrointestinal and psychiatric…
Primary: To investigate if CVL-865 decreases subjective anxiety symptoms elicited by a 35% CO2 inhalation challenge.Secondary: To investigate if CVL-865 decreases subjective fear symptoms elicited by a 35% CO2 inhalation challenge. To investigate if…
Part 1:Primary Objective- To investigate whether repeated dose GRX-917 reduces panic symptoms elicited by an experimental 35% CO2 -induced fear challenge administered in healthy CO2-sensitive subjects. Secondary Objectives- To investigate whether…
The aim is to determine on the basis of the results of this study whether there is measurable effect on the ability to drive after long term use of ICADTS class III drugs. To achieve this goal drugs will be tested out of the groups most commonly…
ObjectivesPrimary:• To assess the effect of ethanol compared to placebo on a driving simulator performance tests;• To assess the effect of alprazolam compared to placebo on a driving simulator performance tests;Secondary:• To assess the effect of…
The primary objectives are:- To investigate the safety and tolerability of JNJ-61393215 after multiple consecutive dose administrations;- To characterize the pharmacokinetics (PK) of JNJ-61393215 in plasma after multiple consecutive dose…
The primary objective of this study is to evaluate the pharmacodynamics (PD) (apolipoproteins/lipid particles and cholesterol efflux) of obicetrapib in cerebrospinal fluid (CSF) and plasma (apolipoproteins/lipid particles) in patients with early…
Synopsis, page 4-5OBJECTIVES:The primary objective of this study is to evaluate the effect of obicetrapib on LDL-C levels at Day 84.The secondary objectives of this study include the following:• To evaluate the effect of obicetrapib on LDL-C levels…
The primary objective of this study is to evaluate the effect of obicetrapib on the risk of major adverse CV events (MACE), including CV death, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization.
The primary objective of this study is to evaluate the effect of obicetrapib on LDL-C levels at Day 84. The secondary objectives of this study include the following: - To evaluate the effect of obicetrapib on fasting apolipoprotein B (ApoB), non-…
To compare PFS of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes treated with RT plus TMZ combined with nivolumab or placebo. PFS will be determined by BICR based on RANO criteria.To compare OS of subjects with newly-…