Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

NCT02064868 | Terminated Phase 3 Results DMC

• 2 other identifiers: CRLX030A33012013-002513-35
• Study Type: interventional
• Target: 2,666
• Locations: 23 countries
• Sites: 312

Brief Summary

This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).

Conditions

Acute Heart Failure (AHF)

Keywords

AHF,; RLX030,; SOC,; WHF,; RELAX-AHF-EU; Renal Impairment

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5

  In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.

  5 days

Secondary Outcomes (6)

• Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14

  14 days

• Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5

  5 days

• Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14

  14 days

• Length of Index Hospital Stay

  30 Days

• Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients

  Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days

Study Arms (2)

Serelaxin + Standard of Care

EXPERIMENTAL

Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.

Drug: Serelaxin; Drug: Standard of Care

Standard of Care (SOC)

OTHER

All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Drug: Standard of Care

Interventions

Serelaxin DRUG

30 µg/kg/day IV infusion

Also known as: RLX030

Serelaxin + Standard of Care

Standard of Care DRUG

This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Serelaxin + Standard of Care; Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systolic blood pressure ≥ 125 mmHg
• Admitted for Acute Heart Failure (AHF)
• Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening
• eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m\^2

You may not qualify if:

• Dyspnea (non-cardiac causes)
• T \> 38.5°C
• Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
• Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \<1.0 cm\^2 or mean gradient \>50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.
• AHF due to significant arrhythmias
• Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (357)

Novartis Investigative Site

Feldkirch, A-6807, Austria

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Novartis Investigative Site

Graz, 8020, Austria

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Novartis Investigative Site

Linz, A-4020, Austria

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Novartis Investigative Site

Salzburg, 5010, Austria

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Novartis Investigative Site

Salzburg, A-5020, Austria

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Novartis Investigative Site

Sankt Pölten, 3100, Austria

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Novartis Investigative Site

Vienna, 1130, Austria

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Novartis Investigative Site

Vienna, A-1020, Austria

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Novartis Investigative Site

Vienna, A-1160, Austria

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Novartis Investigative Site

Aalst, 9300, Belgium

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Bruges, 8000, Belgium

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Brussels, 1090, Belgium

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Hasselt, 3500, Belgium

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Leuven, 3000, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Lodelinsart, 6042, Belgium

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Mol, 2400, Belgium

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Mons, 7000, Belgium

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Roeselare, 8800, Belgium

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Ronse, 9600, Belgium

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Turnhout, 2300, Belgium

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Gabrovo, 5300, Bulgaria

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Plovdiv, 4000, Bulgaria

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Rousse, 7002, Bulgaria

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Sliven, 8800, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1431, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Varaždin, HRV, 42000, Croatia

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Zagreb, 10000, Croatia

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Brno, Czech Republic, 656 91, Czechia

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Decin II, Czech Republic, 405 99, Czechia

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Karvina-Raj, Czech Republic, 73412, Czechia

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Kroměříž, Czech Republic, 767 55, Czechia

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Mělník, Czech Republic, 27601, Czechia

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Písek, Czech Republic, 39701, Czechia

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Svitavy, Czech Republic, 568 25, Czechia

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Tábor, Czech Republic, 39003, Czechia

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Třebíč, Czech Republic, 674 01, Czechia

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Pilsen, 301 00, Czechia

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Prague, 150 06, Czechia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Turku, 20520, Finland

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Marseille, Bouches Du Rhone, 13915, France

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Nancy, Cedex, 54035, France

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Abbeville, 80100, France

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Agen, 47923, France

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Amiens, 80054, France

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Avignon, 84000, France

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Belfort, 90 016, France

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Besançon, 25030, France

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Brest, 29200, France

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Bron, 69677, France

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Chalon-sur-Saône, 71321, France

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Chambray-lès-Tours, 37170, France

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Châteauroux, 36000, France

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Clermont-Ferrand, 63003, France

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Corbeil-Essonnes, 91100, France

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Dunkirk, 59385, France

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La Seyne-sur-Mer, 83500, France

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Le Coudray, 28630, France

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Le Mans, 72037, France

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Lens, 62307, France

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Limoges, 87042, France

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Lorient, 56322, France

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Metz, 57085, France

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Montauban, 82013, France

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Montauban, 82017, France

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Montpellier, 34295, France

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Mulhouse, 68070, France

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Niort, 79021, France

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Nîmes, 30029, France

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Orléans, 45100, France

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Paris, 75010, France

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Paris, 75013, France

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Paris, 75015, France

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Pau, 64000, France

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Périgueux, 24019, France

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Poitiers, 86021, France

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Rennes, 35033, France

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Saint-Brieuc, 22027, France

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Saint-Michel-sur-Orge, 16470, France

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Saint-Priest-en-Jarez, 42277, France

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Strasbourg, 67091, France

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Troyes, 10003, France

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Vienne, 38209, France

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Flensburg, Schleswig-Holstein, 24939, Germany

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Arnstadt, 99310, Germany

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Bad Berka, 99438, Germany

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Bad Oeynhausen, 32545, Germany

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Baden-Baden, 76532, Germany

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Berlin, 10405, Germany

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Berlin, 12203, Germany

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Berlin, 12526, Germany

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Berlin, 12683, Germany

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Berlin, 13187, Germany

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Bernburg, 06406, Germany

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Bochum, 44791, Germany

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Buchholz in der Nordheide, 21244, Germany

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Chemnitz, 09113, Germany

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Chemnitz, 09117, Germany

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Dorsten, 46282, Germany

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Dortmund, 44263, Germany

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Dortmund, 44309, Germany

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Dortmund, 44379, Germany

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Dresden, 01307, Germany

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Duisburg, 47137, Germany

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Duisburg, 47228, Germany

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Düssledorf, 40217, Germany

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Erfurt, 99089, Germany

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Erfurt, 99097, Germany

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Erlangen, 91054, Germany

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Eschwege, 37269, Germany

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Esslingen am Neckar, 73730, Germany

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Frankfurt, 60316, Germany

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Frankfurt, 65929, Germany

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Friesoythe, 26169, Germany

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Gera, 07548, Germany

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Gotha, 99867, Germany

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Greifswald, 17475, Germany

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Gütersloh, 33332, Germany

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Hamburg, 22457, Germany

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Heidelberg, 69120, Germany

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Heidenheim, 89522, Germany

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Hennigsdorf, 16761, Germany

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Herford, 32049, Germany

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Hoyerswerda, 02977, Germany

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Kaufbeuren, 87600, Germany

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Koblenz, 56073, Germany

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Koeln-Nippes, 50733, Germany

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Langen, 63225, Germany

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Lemgo, 32657, Germany

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Leverkusen, 51379, Germany

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Lüneburg, 21339, Germany

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Mannheim, 68167, Germany

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Marburg, 35039, Germany

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Marl, 45768, Germany

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Memmingen, 87700, Germany

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Mönchengladbach, 41063, Germany

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Mülheim, 45468, Germany

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München, 81379, Germany

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Neumünster, 24534, Germany

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Neunkirchen, 66538, Germany

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Neuss, 41464, Germany

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Neustadt A.d. Aisch, 91413, Germany

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Neuwied, 56564, Germany

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Nuremberg, 90419, Germany

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Ribnitz-Damgarten, 18311, Germany

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Rostock, 18057, Germany

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Rotenburg (Wümme), 27356, Germany

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Schönebeck, 39218, Germany

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Schwabach, 91126, Germany

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Schwalmstadt, 34613, Germany

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Singen, 78224, Germany

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Soest, 59494, Germany

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Sonneberg, 96515, Germany

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Speyer, 67346, Germany

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Stade, 21682, Germany

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Stadtlohn, 48703, Germany

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Stuttgart, 70376, Germany

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Suhl, 98527, Germany

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Torgau, 04860, Germany

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Trier, 54292, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Vechta, 49377, Germany

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Wesel, 46483, Germany

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Witten, 58455, Germany

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Worms, 67550, Germany

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Wuppertal, 42109, Germany

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Wurzen, 04808, Germany

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Würzburg, 97078, Germany

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Alexandroupoli, Evros, 681 00, Greece

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Voula, GR, 166 73, Greece

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Athens, 115 21, Greece

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Athens, 115 27, Greece

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Athens, 115 28, Greece

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Volos, GR 38222, Greece

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Budapest, 1096, Hungary

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Budapest, H 1096, Hungary

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Budapest, H-1032, Hungary

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Budapest, H-1115, Hungary

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Debrecen, 4032, Hungary

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Eger, H-3300, Hungary

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Győr, H-9023, Hungary

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Kalocsa, 6300, Hungary

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Kecskemét, 6000, Hungary

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Kistarcsa, 2143, Hungary

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Makó, 6900, Hungary

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Szeged, H-6725, Hungary

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Szolnok, 5004, Hungary

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Reykjavik, IS-101, Iceland

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San Benedetto del Tronto, AP, 63039, Italy

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Arezzo, AR, 52100, Italy

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Acquaviva delle Fonti, BA, 70021, Italy

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Altamura, BA, 70022, Italy

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Cassano delle Murge, BA, 70020, Italy

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Treviglio, BG, 24047, Italy

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Cagliari, CA, 09134, Italy

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Catania, CT, 95100, Italy

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Lodi, LO, 26900, Italy

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Latina, LT, 04100, Italy

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Messina, ME, 98125, Italy

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Cernusco sul Naviglio, MI, 20063, Italy

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Legnano, MI, 20025, Italy

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Matera, Mount, 75100, Italy

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Piacenza, PC, 29100, Italy

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Pordenone, PN, 33170, Italy

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Reggio Emilia, RE, 42123, Italy

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Scandiano, RE, 42019, Italy

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Roma, RM, 00135, Italy

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Roma, RM, 00152, Italy

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Roma, RM, 00177, Italy

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Roma, RM, 00189, Italy

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Siena, SI, 53100, Italy

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Syracuse, SR, 96100, Italy

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Sassari, SS, 07100, Italy

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Orbassano, TO, 10043, Italy

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Torino, TO, 10153, Italy

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Torino, TO, 10154, Italy

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Busto Arsizio, VA, 21052, Italy

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Chioggia, VE, 30015, Italy

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Vicenza, VI, 36100, Italy

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Verona, VR, 37134, Italy

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Vibo Valentia, VV, 89900, Italy

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Pozzuoli, 80078, Italy

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Daugavpils, LV-5417, Latvia

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Kaunas, LTU, LT-50161, Lithuania

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Kaunas, LT, LT-45130, Lithuania

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Klaipėda, 92288, Lithuania

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Vilnius, LT-08661, Lithuania

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Krakow, POL, 31-121, Poland

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Biłgoraj, 23-400, Poland

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Gdansk, 80 952, Poland

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Grodzisk Mazowiecki, 05-825, Poland

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Kielce, 25-317, Poland

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Krakow, 30-901, Poland

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Krakow, 31 501, Poland

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Lubin, 59-301, Poland

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Lublin, 20-718, Poland

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Oświęcim, 32-600, Poland

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Rzeszów, 35-241, Poland

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Tarnobrzeg, 39-400, Poland

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Tarnów, 33-100, Poland

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Wałbrzych, 58-309, Poland

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Almada, 2801 951, Portugal

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Barreiro, 2834-003, Portugal

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Braga, 4710243, Portugal

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Lisbon, 1495-005, Portugal

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Lisbon, 1500 650, Portugal

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Matosinhos Municipality, 4454-509, Portugal

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Setúbal, 2910-446, Portugal

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Vila Franca de Xira, 2600-009, Portugal

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Bucharest, District 4, 4204179, Romania

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Bucharest, Jud Cluj, 010825, Romania

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Craiova, Jud. Iasi, 200642, Romania

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Bucharest, 022322, Romania

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Sibiu, 550245, Romania

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Târgovişte, 130095, Romania

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Chelyabinsk, 454000, Russia

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Chelyabinsk, 454092, Russia

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Chita, 672039, Russia

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Gatchina, 188300, Russia

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Izhevsk, 426009, Russia

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Kazan', 420012, Russia

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Kazan', 420103, Russia

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Kirov, 610027, Russia

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Krasnoyarsk, 660022, Russia

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Moscow, 115280, Russia

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Moscow, 117997, Russia

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Moscow, 121359, Russia

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Moscow, 127473, Russia

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Moscow, 127994, Russia

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Novosibirsk, 630003, Russia

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Penza, 440026, Russia

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Petrozavodsk, 185031, Russia

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Rostov-on-Don, 344068, Russia

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Ryazan, 390026, Russia

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Saint Petersburg, 194044, Russia

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Saratov, 410028, Russia

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Tyumen, 625023, Russia

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Ufa, 450071, Russia

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Vladivostok, 690002, Russia

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Volgograd, 400008, Russia

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Yaroslavl, 150047, Russia

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Zelenograd, Moscow Region, 124489, Russia

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Belgrade, 11 000, Serbia

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Belgrade, 11000, Serbia

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Belgrade, 11080, Serbia

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Kamenica, 21204, Serbia

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Niš, 18000, Serbia

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Niška Banja, 18205, Serbia

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Dunajská Streda, Slovak Republic, 92901, Slovakia

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Skalica, Slovak Republic, 909 82, Slovakia

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Zvolen, Slovak Republic, 96001, Slovakia

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Brezno, 97701, Slovakia

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Poprad, 05845, Slovakia

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Trenčín, 91171, Slovakia

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Celje, 3000, Slovenia

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Jesenice, 4270, Slovenia

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Ljubljana, 1000, Slovenia

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Murska Sobota, 9000, Slovenia

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Granada, Andalusia, 18012, Spain

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Granada, Andalusia, 18014, Spain

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Málaga, Andalusia, 29010, Spain

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Sanlúcar de Barrameda, Andalusia, 11540, Spain

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Seville, Andalusia, 41009, Spain

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Seville, Andalusia, 41013, Spain

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Seville, Andalusia, 41014, Spain

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Bilbao, Basque Country, 48013, Spain

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Galdakano, Basque Country, 48960, Spain

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Villamartín, Cadiz, 11650, Spain

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Salamanca, Castille and León, 37007, Spain

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Soria, Castille and León, 42005, Spain

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Toledo, Castille-La Mancha, 45071, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Lleida, Catalonia, 25198, Spain

Location

Novartis Investigative Site

Terrassa, Catalonia, 08227, Spain

Location

Novartis Investigative Site

Cáceres, Extremadura, 10003, Spain

Location

Novartis Investigative Site

A Coruña, Galicia, 15006, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Las Palmas de Gran Canaria, Las Palmas de G.C, 35010, Spain

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Novartis Investigative Site

Alcorcón, Madrid, 28922, Spain

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Novartis Investigative Site

Fuenlabrada, Madrid, 28942, Spain

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Cartagena, Murcia, 30202, Spain

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El Palmar, Murcia, 30120, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

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Alicante, Valencia, 03010, Spain

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Alicante, Valencia, 03550, Spain

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Alzira, Valencia, 46600, Spain

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Manises, Valencia, 46940, Spain

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Novartis Investigative Site

Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46014, Spain

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Valencia, Valencia, 46015, Spain

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Valencia, Valencia, 46017, Spain

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Novartis Investigative Site

León, 24080, Spain

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Novartis Investigative Site

Madrid, 28006, Spain

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Novartis Investigative Site

Madrid, 28040, Spain

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Murcia, 30003, Spain

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Zaragoza, 50009, Spain

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Novartis Investigative Site

Basel, 4031, Switzerland

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Geneva, 1211, Switzerland

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Liestal, 4410, Switzerland

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Novartis Investigative Site

Lugano, 6903, Switzerland

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Durham, County Durham, DH1 5TW, United Kingdom

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Dorchester, Dorset, DT1 2JY, United Kingdom

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Peterborough, GBR, PE3 6DA, United Kingdom

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Gateshead, Tyne and Wear, NE9 6SX, United Kingdom

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Barnet, EN5 3DJ, United Kingdom

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Cardiff, CF14 4XW, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Liverpool, L9 7AL, United Kingdom

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London, SW17 ORE, United Kingdom

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Swindon, SN3 6BB, United Kingdom

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Related Publications (2)

• Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.

  PMID: 35184572 DERIVED

• Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.

  PMID: 34514815 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

serelaxin protein, human; Standard of Care

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: January 31, 2014
• Primary Completion: March 26, 2017
• Study Completion: April 25, 2017
• Last Updated: March 22, 2019
• Results First Posted: March 22, 2019

Record last verified: 2018-12

Locations

HU (13); CH (4); CZ (11); PT (8); DE (86); RO (6); RU (27); FI (1); FR (43); ES (2); IT (34); GR (6); BE (13); AU (9); BU (7); PL (14); SL (4); IC (1); SE (6); GB (10); LI (4); LA (1); CR (2)