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Clinical trials for Sacubitril

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   44336   clinical trials with a EudraCT protocol, of which   7366   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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    36 result(s) found for: Sacubitril. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2015-004207-22 Sponsor Protocol Number: CLCZ696B2319 Start Date*: 2017-04-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Multicenter, open-label, study to evaluate safety, tolerability, pharmacokinetics and, pharmacodynamics of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled s...
    Medical condition: Pediatric heart failure 1 month to <18 years old
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10019279 Heart failure LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) NL (Ongoing) SE (Completed) NO (Completed) ES (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) IT (Completed) FR (Completed) BG (Completed) PL (Completed) HU (Completed) HR (Completed) AT (Completed) PT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-003085-32 Sponsor Protocol Number: CLCZ696B3301 Start Date*: 2016-11-14
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, prospective, randomized, double-blind study to assess the impact of sacubitril/valsartan vs. enalapril on daily physical activity using a wrist worn actigraphy device in adult chron...
    Medical condition: Heart Failure with reduced ejection fraction (HFrEF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) SE (Completed) EE (Completed) DK (Completed) LV (Completed) BE (Completed) ES (Completed) FI (Completed) FR (Completed) BG (Completed) NL (Completed) IS (Completed) GR (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-004882-15 Sponsor Protocol Number: EntREG-SILICOFCM Start Date*: 2019-05-21
    Sponsor Name:University Hospital Regensburg
    Full Title: Effect of angiotensin receptor neprilysin inhibitor sacubitril/valsartan on cardiopulmonary exercise tolerance in patients with hypertrophic cardiomyopathy – a randomized controlled clinical Phase ...
    Medical condition: hypertrophic cardiomyopathy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003888-22 Sponsor Protocol Number: MEF-HF-2020-01 Start Date*: 2020-11-17
    Sponsor Name:University of Zagreb School of Medicine
    Full Title: A multicENter, randomized, open-label, parallel group, pilot study to evaluate the use of sacubitril/valsartan in HeartMate 3 LVAD recipients
    Medical condition: Heart failure Heart failure with reduced ejection fraction Advanced Heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HR (Ongoing) NL (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004154-25 Sponsor Protocol Number: CLCZ696B2319E1 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter study to evaluate long-term safety and tolerability of open label sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction wh...
    Medical condition: Pediatric heart failure : Patients (≥ 13 months) with HF due to systemic left ventricular systolic dysfunction. [Note: All patients per protocol for the core study CLCZ696B2319 (PANORAMA-HF) ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10019279 Heart failure LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Completed) FR (Completed) BG (Completed) PT (Completed) CZ (Completed) ES (Ongoing) HU (Completed) HR (Completed) DE (Completed) AT (Completed) IT (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2017-001803-57 Sponsor Protocol Number: CLCZ696B2126 Start Date*: 2017-08-14
    Sponsor Name:Novartis Pharmaceuticals Corp
    Full Title: A randomized, study in healthy subjects to determine the bioavailability of 200 mg LCZ696 mini-tablet compared to the 200 mg LCZ696 final market image tablet
    Medical condition: Study in healthy subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002113-64 Sponsor Protocol Number: CLCZ696BFI03 Start Date*: 2017-11-27
    Sponsor Name:Novartis Finland Oy
    Full Title: Controlled trial on the short-term effects of sacubitril/valsartan therapy on cardiac oxygen consumption and efficiency of cardiac work in patients with NYHA II-III heart failure and reduced systol...
    Medical condition: NYHA II-III heart failure and reduced systolic function
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2023-001004-33 Sponsor Protocol Number: CLCZ696B2319E2 Start Date*: 2025-01-20
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Safety Study of Sacubitril/​Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
    Medical condition: Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10019280 Heart failures HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003098-24 Sponsor Protocol Number: CLCZ696I12201 Start Date*: 2019-12-18
    Sponsor Name:Novartis Pharma AG
    Full Title: A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardio...
    Medical condition: non-obstructive hypertrophic cardiomyopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10020871 Hypertrophic cardiomyopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) FI (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002154-20 Sponsor Protocol Number: CLCZ696G2301 Start Date*: 2017-03-28
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, randomized, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk ...
    Medical condition: Left ventricular dysfunction following an acute myocardial infarction.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10000891 Acute myocardial infarction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) GR (Completed) AT (Completed) SK (Completed) NL (Completed) ES (Completed) HU (Completed) BE (Completed) DK (Completed) SE (Completed) FI (Completed) BG (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-003046-13 Sponsor Protocol Number: 2021/ABM/03/00008 Start Date*: 2023-11-27
    Sponsor Name:Śląskie Centrum Chorób Serca
    Full Title: Sacubitril/Valsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent. Randomized, multicenter, double-blind, placebo-controlled study.
    Medical condition: Heart failure – post-anthracycline cardiomyopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003410-28 Sponsor Protocol Number: CLCZ696D2302 Start Date*: 2017-06-05
    Sponsor Name:Novartis Pharma AG
    Full Title: A 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the effect of LCZ696 on NT-proBNP, exercise capacity, symptoms and safety compared to individu...
    Medical condition: Heart Failure with preserved Ejection Fraction (HFpEF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) LV (Completed) ES (Completed) FR (Completed) SK (Completed) CZ (Completed) GB (Completed) LT (Completed) AT (Completed) DK (Completed) BG (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000394-36 Sponsor Protocol Number: M17-05-LCZ-ARNI Start Date*: 2017-12-20
    Sponsor Name:Hannover Medical School
    Full Title: Influences of angiotensin-neprilysin inhibition with Sacubitril/Valsartan (ENTRESTO®) on centrally generated sympathetic activity in heart failure patients
    Medical condition: Chronic heart failure with reduced left ventricular ejection fraction (NYHA II-III)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10078289 Heart failure with reduced ejection fraction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000220-33 Sponsor Protocol Number: CLCZ696BDE03 Start Date*: 2019-02-04
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A randomized, double-blind, active-controlled study to assess the effect of sacubitril/valsartan compared with enalapril to improve erectile function in patients with heart failure with reduced eje...
    Medical condition: Patients with heart failure with reduced ejection fraction (HFrEF) and erectile dysfunction (ED)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10008502 CHF LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003266-87 Sponsor Protocol Number: CLCZ696B2401 Start Date*: 2016-03-02
    Sponsor Name:Novartis Pharma services AG
    Full Title: A multicenter, randomized, open label, parallel group study comparing pre-discharge and posT-discharge tReatment initiation with LCZ696 in heArt failure patieNtS with reduced ejectIon-fracTion hosp...
    Medical condition: Heart Failure with reduced ejection fraction (HF-rEF) stabilized after hospitalization due to acute decompensated heart failure episode.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) SK (Completed) PT (Completed) SE (Completed) ES (Completed) CZ (Completed) FR (Completed) BE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000213-23 Sponsor Protocol Number: NL60561.078.17 Start Date*: 2017-07-21
    Sponsor Name:
    Full Title: ARNI-study: ARNI or ARB to arrest progression of nephropathy.
    Medical condition: Chronic kidney disease with concurrent hypertension and diabetes.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006994-48 Sponsor Protocol Number: EMPATICC-INCOR1 Start Date*: 2022-07-25
    Sponsor Name:Universitätsklinikum Essen
    Full Title: Empower the Heart of Patients with Terminal Cancer using Cardiac Medicines Trial
    Medical condition: Patients with terminal cancer in palliative care
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10059513 Palliative care PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003906-29 Sponsor Protocol Number: CLCZ696G2301E1 Start Date*: 2021-02-08
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter study to evaluate the long-term safety and tolerability of open-label LCZ696 in patients with acute myocardial infarction who previously participated in CLCZ696G2301 (PARADISE-MI)
    Medical condition: Left ventricular dysfunction following an acute myocardial infarction and/or pulmonary congestion requiring intravenous treatment
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10000891 Acute myocardial infarction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GR (Prematurely Ended) NO (Prematurely Ended) CZ (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005302-26 Sponsor Protocol Number: DW.0701.005.2020P Start Date*: 2023-01-05
    Sponsor Name:John Paul II Hospital
    Full Title: The effect of sacubitril/valsartan versus ramipril on left ventricular function and remodeling in patients with ischemic heart failure with mid-range ejection fraction
    Medical condition: heart failure with moderately reduced ejection fraction (HFmrEF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10010684 Congestive heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001971-30 Sponsor Protocol Number: CLCZ696B2317 Start Date*: 2014-11-22
    Sponsor Name:Novartis Pharma services AG
    Full Title: A multicenter study to evaluate safety and tolerability in patients with chronic heart failure and reduced ejection fraction from PARADIGM-HF receiving open label LCZ696
    Medical condition: Heart failure with reduced ejection fraction
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004849 10019279 Heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) LT (Completed) FI (Completed) NL (Completed) CZ (Completed) SE (Completed) SK (Completed) HU (Completed) PT (Completed) DK (Completed) EE (Completed) ES (Completed) IT (Completed) DE (Completed) BE (Completed) BG (Completed) FR (Completed) PL (Completed)
    Trial results: View results
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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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