Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
NCT ID: NCT02151383
Last Updated: 2019-06-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2014-09-05
2017-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Serelaxin
Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours.
Serelaxin
Serelaxin was administered intravenously for up to 48 hours.
Interventions
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Serelaxin
Serelaxin was administered intravenously for up to 48 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hospitalized in an intensive care unit or step-down unit with the following:
* \- Signs and symptoms of acute heart failure of any etiology
* \- Stable dose of vasoactive and/or inotropic drugs
* \- For non-surgical patients echocardiographic evidence of reduced ventricular function (ejection fraction \<50% or fractional shortening \<28%)
* Systolic blood pressure (SBP) ≥25th percentile SBP for age and gender.
Exclusion Criteria
* Single ventricle physiology
* Fixed pulmonary hypertension
* Blood lactate levels \>5 mmol/L at screening
* Birth \< 36 weeks post-conceptual age (for patients \<1year old)
* Confirmed or clinically suspected systemic infection or severe localized infection
* Dyspnea or acute lung injury primarily due to non-cardiac causes
* Patients with severe renal impairment, those known to have significant renal disease and those having renal replacement therapy
* High use of inotropic and/or vasoactive agents at screening
* Electrocardiographic abnormalities
* Solid organ transplant recipient within 1 year of transplantation or one who presents with severe organ rejection
17 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
The Bronx, New York, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Freiburg im Breisgau, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Geneva, , Switzerland
Novartis Investigative Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-002847-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRLX030A2208
Identifier Type: -
Identifier Source: org_study_id
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