8 results
Primary:Assess the safety of repeat doses of serelaxin in chronic heart failureSecondary:- Assess the incidence rate of adverse events of special interest, indicative of hypersensitivity reactions- Assess the safety and tolerability of repeated…
The objectives of this phase of the study are to confirm the efficacy of IV relaxin, in addition to standard therapy, in improving symptoms of heart failure, dyspnea, and in preventing intermediate term re-admission for HF or renal failure and…
To compare tumor [11C]erlotinib pharmacokinetics in NSCLC patients with and without erlotinib therapy. Also, to assess the relationship of venous sampling versus arterial, of tumor [11C]erlotinib uptake and blood flow with and without therapy, and…
Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…
Primary Objective: To study the tumour pharmacokinetics of [11C]erlotinib in NSCLC patients in vivo and relating uptake with EGFR mutations, obtained from tumour biopsies. Secondary Objective(s): 1. to define the test-retest reproducibility of [11C]…
Primary objective(s)To assess the effects of 24 hrs i.v. infusion of RLX030 30µg/kg/day compared to placebo on renal blood flow (RBF) as measured by PAH clearance in subjects with CHF and worsening symptoms To assess the effects of 24 hrs i.v.…
Primary Objective:To demonstrate that serelaxin is superior to placebo in reducing CV death in AHF patients during a follow-up period of 180 days.To demonstrate that serelaxin is superior to placebo in reducing worsening heart failure through Day…
To evaluate interlesional and intralesional differences in [11C]erlotinib uptake in EGFR mutated (EGFR+) NSCLC patients who are at different stages in their TKI treatment. To correlate tumor [11C]erlotinib uptake to EGFR mutational status, tumor…