At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 321 enrolled
Drug / intervention
RLX030 (serelaxin) +1 moredrug
Likely dose
RLX030 (serelaxin) 30 μgfrom 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.
Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
In Brief
A Phase 2 clinical trial evaluating RLX030 (serelaxin) and Placebo for Chronic Heart Failure. Completed, enrolled 321 participants across 52 sites in 13 countries.
Detailed Summary
The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure
CountriesAustralia, Czechia, Finland, Germany, Italy, Netherlands, Norway, Romania, Russia, Spain, Sweden, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartMay 2014
Primary CompletionSep 2015
TodayJul 2026
First PostedNov 13, 2013
Enrollment StartMay 1, 2014
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.6 years ago
Interventions
RLX030 (serelaxin)drug
RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours.
Placebodrug
Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.