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Clinical trials for Serelaxin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44344   clinical trials with a EudraCT protocol, of which   7373   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    11 result(s) found for: Serelaxin. Displaying page 1 of 1.
    EudraCT Number: 2015-004031-12 Sponsor Protocol Number: AC15007 Start Date*: 2017-01-05
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: Serelaxin To Lower Portal Pressure in Patients with Cirrhosis and Portal Hypertension (STOPP)
    Medical condition: Portal hypertension in patients with liver cirrhosis.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10036200 Portal hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002781-39 Sponsor Protocol Number: CRLX030A2209 Start Date*: 2014-05-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects with Chronic Heart Failure
    Medical condition: chronic heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) FI (Completed) ES (Completed) SE (Completed) NO (Completed) RO (Completed) NL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-005054-30 Sponsor Protocol Number: CamiciSerelaxin2013_CRLX030AIT01T Start Date*: 2014-06-10
    Sponsor Name:Ospedale San Raffaele s.r.l.
    Full Title: A mechanistic study to evaluate the effect of Serelaxin on left ventricular function and its correlation with outcome in acute heart failure
    Medical condition: Acute Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004849 10000803 Acute heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-002673-38 Sponsor Protocol Number: CRLX030A2211 Start Date*: 2015-11-24
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, double-blind, crossover placebo-controlled Phase II study to assess the effect of serelaxin versus placebo on high sensitivity cardiac troponin I (hs-cTnI) release in pat...
    Medical condition: Chronic Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004849 10008908 Chronic heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001945-42 Sponsor Protocol Number: CRLX030A2203 Start Date*: 2013-09-26
    Sponsor Name:Novartis Pharma Service AG
    Full Title: A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the effects of intravenous serelaxin infusion on micro- and macrovascular function in patients with cor...
    Medical condition: Coronary artery disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 10007541 - Cardiac disorders 10011078 Coronary artery disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002513-35 Sponsor Protocol Number: CRLX030A3301 Start Date*: 2013-11-28
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, prospective, randomized, open label study to assess the effect of serelaxin versus standard of care in acute heart failure (AHF) patients.
    Medical condition: Acute heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) AT (Prematurely Ended) HU (Prematurely Ended) IT (Prematurely Ended) CZ (Prematurely Ended) SK (Prematurely Ended) BE (Completed) PT (Prematurely Ended) BG (Completed) LT (Completed) PL (Prematurely Ended) LV (Prematurely Ended) EE (Completed) FI (Prematurely Ended) SI (Prematurely Ended) GR (Prematurely Ended) ES (Prematurely Ended) HR (Prematurely Ended) DK (Prematurely Ended) IS (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-001498-25 Sponsor Protocol Number: CRLX030A2301 Start Date*: 2013-09-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, double-blind, placebo-controlled phase IIIb study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure pa...
    Medical condition: Acute heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BE (Completed) SE (Completed) IE (Completed) BG (Completed) HU (Completed) PT (Completed) LT (Prematurely Ended) IT (Completed) CZ (Completed) AT (Completed) EE (Completed) DK (Completed) ES (Completed) LV (Prematurely Ended) NL (Completed) GR (Completed) GB (Completed) PL (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2012-000236-26 Sponsor Protocol Number: CRLX030X2201 Start Date*: 2012-11-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An exploratory study to investigate the haemodynamic effects of serelaxin in patients with compensated cirrhosis and portal hypertension
    Medical condition: Compensated alcohol-related cirrhosis and portal hypertension
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004871 10020786 Hypertension portal LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002847-28 Sponsor Protocol Number: CRLX030A2208 Start Date*: 2014-06-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Multicenter, open-label, dose escalation study to evaluate safety, tolerability and pharmacokinetics of RLX030 in addition to standard of care in pediatric patients from birth to <18 years of age, ...
    Medical condition: acute heart failure
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10000803 Acute heart failure LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001617-14 Sponsor Protocol Number: CRLX030A2205 Start Date*: 2012-08-17
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An adaptive multicentre, randomized, partially doubleblind, placebo controlled study to assess the safety, PK and PD/efficacy of RLX030 in women with pre-eclampsia
    Medical condition: Pre-eclampsia
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004868 10027620 Mild or unspecified pre-eclampsia LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-002257-19 Sponsor Protocol Number: CARDIORYC-2014-001 Start Date*: 2015-04-21
    Sponsor Name:Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
    Full Title: Single-center, randomized, open, controlled by echocardiography to evaluate the effect of serelaxina in the functioning of the right ventricle and its potential in the prognosis of acute heart fail...
    Medical condition: ICA hospitalized patients with high normal blood pressure, and mild to moderate renal failure at the time of selection
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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