82 results
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary: To assess the effect of UT-15C SR…
To describe the safety and tolerability of up to 5 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab.
To assess the efficacy of treatment with monochloroacetic compared to treatment with cryotherapy regarding patients with handwarts and compared to combination therapy (salicylic acid and cryotherapy) regarding patients with plantar warts.WARTS-1 has…
To establish the safety and and tolerability and early efficacy of Alkaline phosphatase in the treatment of sepsis patients with renal failure.
The objectives are to evaluate the safety and efficacy of TRC4186 and to define the recommended dose level for further pivotal studies.
Primary objective:* To determine the safety, tolerability, dose-limiting toxicities (DLT), maximum acceptable dose (MAD) and maximum tolerated dose (MTD) of CHR-2845 when administered orally to patients with advanced or treatment refractory…
The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…
Primary Objectives:1. To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placeboon plasma concentrations of LDL-C (BQ method).2. To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placeboon plasma…
Primary objectives:* To assess telmisartan target (i.e. receptor) specific binding in vivo* To assess receptor occupancy of telmisartan in vivo* To determine optimal scanning time in vivoSecondary objective:* To explore the effect of telmisartan on…
To assess the safety and tolerability of ascending doses of PP-001 whenadministered as a single intravitreal injection from 0,3 *g, 0,6 *g and 1,2*g with the option of an addition cohort with a dose of 2,1 *g PP-001.To assess the efficacy of…
Primary Objective:To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) andivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and aminimal function mutation (F/MF subjects)Secondary…
Primary Objective:To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)Secondary Objectives:* To evaluate the…
- To assess the relative bioavailability of GLPG2737 administered as a single capsule compared to a single oral suspension in the fed state.- To assess the safety and tolerability in healthy subjects of GLPG2737 administered as a capsule and as an…
Primary Objectives:* Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D, 200mg BID) of TAS-119.
The purpose of this study is to investigate the effect size in order to perform a power calculation for calculating a sample size for a powered RCT
PRIMARY OBJECTIVES- To investigate the PK profile of GLPG2451 administered as two doses of a capsule formulation in healthy subjects.- To assess the safety and tolerability of GLPG2451 administered as two doses of a capsule formulation in healthy…
The primary objective of this feasibility study is to investigate the detection rate of SLNs using MR lymphography.
Primary Efficacy Objectives:The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of exposure to bexagliflozin in type 2 diabetic subjects with increased risk of cardiovascular…
Objective of the phase II POP study:To determine the safety and preliminary anti-tumor activity of AZD1775 in combination with carboplatin in p53 mutated epithelial ovarian cancer in a 21 day schedule.Objectives of the additional safety and…
The primary objective of the study is :To assess MRD negativity rate by NGF after 9 cycles for all eligible ITT patients of KRd versus Rd in patients with high-risk SMMSecondary objectives:• To assess MRD (NGF) negativity rate after 4 cycles of…