NCT02002702

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of Serelaxin When Added to Standard Therapy in Japanese Acute Heart Failure Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Serelaxin	Intravenous infusion
DRUG	Placebo	Placebo

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-12-06
• Last updated: 2015-10-12
• Results posted: 2015-10-12

Locations

15 sites across 1 country: Japan