11 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 purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…
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…
Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…
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(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…
Part 1A:Primary objective is to evaluate the safety and tolerability of ascending single doses of TDT 077 in healthy older male and female subjects. Secondary objective is to evaluate the systemic exposure (PK) of ascending single doses of TDT 077…
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Long-term efficacy.Exploratory: Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (SF-12), Treatment Satisfaction Questionnaire for…
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…
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.
The purpose of this study is to seek regulatory approval for use of fingolimod in a pediatric population with MS aged 10 to less than 18 years old. This study is conducted in line with the Pediatric Investigational Plan agreed with the EMA (under EU…