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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01982292
Registration number
NCT01982292
Ethics application status
Date submitted
6/11/2013
Date registered
13/11/2013
Date last updated
9/11/2016
Titles & IDs
Public title
Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
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Scientific title
Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
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Secondary ID [1]
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2013-002781-39
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Secondary ID [2]
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CRLX030A2209
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Universal Trial Number (UTN)
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Trial acronym
RELAX-REPEAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - RLX030 (serelaxin)
Treatment: Drugs - Placebo
Experimental: 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
Placebo Comparator: Placebo - Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
Treatment: Drugs: 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.
Treatment: Drugs: Placebo
Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks
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Assessment method [1]
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A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.
A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient's antibody status is considered to be undetermined during the study if it is not defined as positive or negative.
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Timepoint [1]
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16 weeks
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Secondary outcome [1]
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Percentage of Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies After a Single Infusion of Serelaxin Over Time up to Week 16
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Assessment method [1]
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A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. Each time period is defined as the time frame from study drug initiation (or the visit if there is no infusion) to prior to study drug initiation of the next period (or the visit if no there is no infusion). n= The total number of subjects with evaluable antibody status during the defined period.
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Timepoint [1]
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Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16
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Secondary outcome [2]
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Antibody Titers in Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies (Neutralizing, Non-neutralizing or Both) at Any Time Following 3 Repeated Infusions and at Week 4, Week 8 and Week 12
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Assessment method [2]
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Timepoint [2]
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Week 4, Week 8, Week 12
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Secondary outcome [3]
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Percentage of Participants With Chronic Heart Failure With Positive Antibody Status Who Develop Non-neutralizing Anti-serelaxin Antibodies Following 3 Repeated Infusions (i.e. at Week 4, Week 8, and Week 12)
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Assessment method [3]
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A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.
n = the total number of subjects with evaluable antibody status after specified number of infusions
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Timepoint [3]
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At Week 4, Week 8, Week 12
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Secondary outcome [4]
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Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions
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Assessment method [4]
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Incidence rate of special interest, indicative of hypersensitivity reactions which occur during and after administration of repeated infusions of serelaxin relative to placebo in subjects with chronic heart failure is reported. Hypersensitivity reactions or infusion reactions can be headache, nausea, fever, chills, dizziness, flush, pruritus, chest and/or back pain.
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Timepoint [4]
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16 weeks
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Secondary outcome [5]
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Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48)
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Assessment method [5]
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Due to sparse PK sampling, AUC 0-48 hours was not analyzed.
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Timepoint [5]
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pre-infusion and 8, 24 and 48 hours post each infusion.
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Secondary outcome [6]
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Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css)
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Assessment method [6]
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Concentration at steady state (Css) was estimated using C48 or C24 for patients who received the intended rate of infusion for at least 24hours. n: Number of patients with valid PK parameters available
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Timepoint [6]
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pre-infusion and 24, 48 hours post each infusion
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Secondary outcome [7]
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Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours
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Assessment method [7]
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This analysis was not done due to sparse PK sampling.
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Timepoint [7]
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48 hours post each infusion
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Secondary outcome [8]
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Pharmacokinetics of RLX030: Clearance of Serelaxin (CL)
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Assessment method [8]
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Clearance (CL) was calculated using concentration at steady state (Css) and the actual delivered dose rate. n: Number of patients with valid PK parameters available within 48 hours post each infusion.
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Timepoint [8]
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48 hours post each infusion
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Eligibility
Key inclusion criteria
Key
- Body weight of = 160 kg.
- 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.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current acute decompensated HF
- 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
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Study design
Purpose of the study
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2015
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Sample size
Target
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Accrual to date
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Final
321
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Geelong
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Recruitment hospital [2]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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3220 - Geelong
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Recruitment postcode(s) [2]
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VIC 3004 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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Florida
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Minnesota
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North Carolina
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Tennessee
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United States of America
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Virginia
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Czech Republic
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Brno - Bohunice
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Czech Republic
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JIhlava
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Czech Republic
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Praha 2
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Finland
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Turku
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Germany
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Niedersachsen
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Frankfurt
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Germany
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Greifswald
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Germany
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Grunstadt
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Germany
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Jena
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Germany
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Kiel
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Germany
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Luebeck
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Germany
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Magdeburg
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Italy
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AR
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Italy
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BS
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Italy
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Groningen
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Rotterdam
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Oslo
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Romania
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Mures
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Romania
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Bucharest
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Romania
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Bucuresti
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Craiova
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Romania
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Sibiu
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Russian Federation
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Moscow
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Spain
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Andalucia
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Spain
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Cadiz
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Spain
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Madrid
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Sweden
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Stockholm
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Diskapi / Ankara
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Haydarpasa/Istanbul
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Sivas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic
heart failure.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01982292
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01982292
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