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Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

NCT01982292 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2016-11-09

Study results available
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Summary

The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.

Conditions

Interventions

DRUG

RLX030 (serelaxin)

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.

DRUG

Placebo

Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States
  • Australia
  • Czechia
  • Finland
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Romania
  • Russia
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01982292 on ClinicalTrials.gov