NCT01870778

Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,600 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

Detailed description

This Phase IIIb outcome study in AHF patients was designed as a multicenter, randomized, double-blind, placebo-controlled, event-driven study in order to assess the efficacy, safety and tolerability of intravenous infusion of serelaxin or placebo. The AHF patients randomized to either serelaxin or placebo in the study were followed for a period of 180 days, and were required to receive standard-of-care background HF management during both the index hospitalization and post discharge according to regional or local guidelines/institutional standards.

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	RLX030	1 mg/mL solution in 6 mL vials
DRUG	Placebo	Matching placebo solution to serelaxin

Timeline

• Start date: 2013-10-02
• Primary completion: 2017-01-23
• Completion: 2017-02-01
• First posted: 2013-06-06
• Last updated: 2018-03-30
• Results posted: 2018-03-30

Locations

540 sites across 35 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom