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Relaxin

Phase 2

Heart Failure, Congestive | Small molecule | Other |Novartis AG|Last Updated: Oct 30, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,179

FDA Designations

No designations recorded

Clinical trial landscape

Relaxin · 2 trials · 1 indication

Phase 2 2
NCT00520806Efficacy and Safety of Relaxin for the Treatment of Acute Heart FailureHeart Failure, Congestive
COMPLETED1,161 Analytics
NCT00259116A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart FailureHeart Failure, Congestive
COMPLETED18 Analytics
PHASE2COMPLETED
Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure
Heart Failure, CongestiveUnlock trial analytics
PHASE2COMPLETED
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Heart Failure, CongestiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Relief of dyspnea in acute heart failure
Up to day 5
Cardiac hemodynamics including PCWP, CO/CI, SVR

Secondary Endpoints

Days alive and out of hospital
Up to day 60
CV death or rehospitalization due to heart failure or renal failure
Up to day 60
Safety and tolerability
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR48 hour iv infusion of placebo
RelaxinEXPERIMENTAL48 hour iv infusion of relaxin at 30 ug/kg/day

Interventions

NameTypeDescription
RelaxinDRUGIntravenous infusion for 48 h at 30 ug/kg/day
PlaceboDRUGIntravenous infusion for 48 h
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Hospitalized for acute heart failure * Dyspnea at rest or with minimal exertion * Pulmonary congestion * Able to provide informed consent * Systolic blood pressure \> 125 mmHg * Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2 Exclusion Criteria: * Use of ot...

Countries:United StatesIsraelGermany
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