drugset / Trial / NCT02002702

Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients

NCT02002702

Phase 2 Completed 46 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-01
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Serelaxin Protein / enzyme biologic 10 ug/kg Intravenous
Subject Serelaxin Protein / enzyme biologic 30 ug/kg Intravenous

Indications