Conditions: Acute Heart Failure
Keywords: Acute heart failure (AHF), Japanese, Safety and tolerability, Pharmacokinetics, Renal Impairment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy, in approximately 45 Japanese AHF patients.

Detailed description:

Arms:
arm 1: Participants received 10 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. arm 2: Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. arm 3: Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.

Interventions: intervention 1: Serelaxin intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous infusion intervention 2: Placebo

Protocol document: