At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 6,600 enrolled
Drug / intervention
RLX030 +1 moredrug
Likely dose
RLX030 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating RLX030 and Placebo for Acute Heart Failure. Completed, enrolled 6,600 participants across 540 sites in 35 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Heart Failure
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartOct 2013
Primary CompletionJan 2017
Study CompletionFeb 2017
TodayJul 2026
First PostedJun 6, 2013
Enrollment StartOct 2, 2013
Primary CompletionJan 23, 2017
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.1 years ago
Interventions
RLX030drug
1 mg/mL solution in 6 mL vials
Placebodrug
Matching placebo solution to serelaxin