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

NCT02007720 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 876

Last updated 2019-08-02

Study results available
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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.

Conditions

  • Acute Heart Failure

Interventions

DRUG

Serelaxin

Intravenous infusion

DRUG

Placebo

Intravenous infusion

OTHER

Standard of CareTherapy

This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-12
Primary Completion
2017-03-27
Completion
2017-06-16

Countries

  • China
  • India
  • Japan
  • Jordan
  • Lebanon
  • Malaysia
  • Philippines
  • Singapore
  • South Korea
  • Taiwan
  • Thailand

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02007720 on ClinicalTrials.gov