At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 46 enrolled
Drug / intervention
Serelaxin +1 moredrug
Likely dose
Not stated in 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 II Study to Assess the Safety, Tolerability and Pharmacokinetics of Serelaxin When Added to Standard Therapy in Japanese Acute Heart Failure Patients
In Brief
A Phase 2 clinical trial evaluating Serelaxin and Placebo for Acute Heart Failure. Completed, enrolled 46 participants across 15 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Heart Failure
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartJan 2014
Primary CompletionAug 2014
TodayJul 2026
First PostedDec 6, 2013
Enrollment StartJan 1, 2014
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.6 years ago
Interventions
Serelaxindrug
Intravenous infusion
Placebodrug
Placebo