7 results
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: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…
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(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: Determine whether treatment with a PI3K inhibitor (BYL719 or buparlisib) plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with hormone receptor-positive HER2-…
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* To explore the pharmacokinetics of insulin aspart after pulsed intra-vaginal delivery using the MedRing and after subcutaneous injection in women with DM1.Secondary* To assess the safety and short-term tolerability of insulin aspart after…