Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
NCT ID: NCT01982292
Last Updated: 2016-11-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
321 participants
INTERVENTIONAL
2014-05-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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RLX030 (serelaxin)
Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
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.
Placebo
Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
Placebo
Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.
Interventions
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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.
Placebo
Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with compensated CHF (NYHA Class II - III) at time of screening with a prior documented history of chronic heart failure.
* NT-proBNP \>300 pg/ml (according to central measurement) at visit 1.
* Subjects treated with appropriate and guideline-indicated CHF standard of care.
* Ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.
Exclusion Criteria
* Any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.
* Documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without ICD (implantable cardioverter defibrillator) with significant hemodynamic consequences within the 3 months prior to screening.
* Presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
* Subjects with severe renal impairment defined as pre-randomization eGFR \< 30 ml/min/1.73m2 calculated using the sMDRD equation and/or those receiving current or planned dialysis or ultrafiltration
18 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
Anaheim, California, United States
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Colorado Springs, Colorado, United States
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Jacksonville, Florida, United States
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South Miami, Florida, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Chapel Hill, North Carolina, United States
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Knoxville, Tennessee, United States
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Richmond, Virginia, United States
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Geelong, , Australia
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Melbourne, , Australia
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Brno - Bohunice, Czech Republic, Czechia
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Jihlava, , Czechia
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Prague, , Czechia
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Turku, Finland, Finland
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Lübeck, Germany, Germany
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Hanover, Lower Saxony, Germany
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Berlin, State of Berlin, Germany
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Berlin, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Greifswald, , Germany
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Grünstadt, , Germany
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Jena, , Germany
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Kiel, , Germany
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Magdeburg, , Germany
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Cortona, AR, Italy
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Brescia, BS, Italy
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Monza, MB, Italy
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Vimercate, MI, Italy
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Sneek, The Netherlands, Netherlands
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Groningen, , Netherlands
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Rotterdam, , Netherlands
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Oslo, , Norway
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Târgu Mureş, Mureș County, Romania
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Bucharest, Romania, Romania
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Bucharest, , Romania
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Craiova, , Romania
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Sibiu, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Villamartín, Cadiz, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Stockholm, , Sweden
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Diskapi / Ankara, , Turkey (Türkiye)
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Haydarpasa/Istanbul, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Meselik / Eskisehir, , Turkey (Türkiye)
Novartis Investigative Site
Sivas, , Turkey (Türkiye)
Countries
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References
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Kumar VA, Wilson SS, Ayaz SI, Levy PD. Targeted biological therapies reach the heart: the case of serelaxin for heart failure. Drugs Today (Barc). 2015 Oct;51(10):591-7. doi: 10.1358/dot.2015.51.10.2386731.
Other Identifiers
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2013-002781-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRLX030A2209
Identifier Type: -
Identifier Source: org_study_id