Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
NCT ID: NCT00549770
Last Updated: 2015-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1334 participants
INTERVENTIONAL
2007-09-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LCZ696 100 mg
Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
LCZ696
Placebo
LCZ696 200 mg
Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
LCZ696
Placebo
LCZ696 400 mg
Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
LCZ696
Placebo
Valsartan 80 mg
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
Valsartan
Placebo
Valsartan 160 mg
Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.
Valsartan
Placebo
Valsartan 320 mg
Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
Valsartan
Placebo
AHU377 200 mg
Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
AHU377
Placebo
Placebo
Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
Placebo
Interventions
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LCZ696
Valsartan
AHU377
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
* Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
* Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP\> 95 mmHg at baseline (Visit 3);
Exclusion Criteria
* History of angioedema, drug-related or otherwise, as reported by the patient
* Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
* History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
* History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease
18 Years
75 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
Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
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Muscle Shoals, Alabama, United States
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Chandler, Arizona, United States
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Buena Park, California, United States
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Fair Oaks, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Orangevale, California, United States
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Santa Ana, California, United States
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Stockton, California, United States
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Tustin, California, United States
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Jacksonville, Florida, United States
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Pembroke Pines, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Chelsea, Michigan, United States
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Royal Oak, Michigan, United States
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Brooklyn Center, Minnesota, United States
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City of Saint Peters, Missouri, United States
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Toms River, New Jersey, United States
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Trenton, New Jersey, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Simpsonville, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Richmond, Virginia, United States
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Charleston, West Virginia, United States
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Corrientes, Corrientes Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Cambridge, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Granby, Quebec, Canada
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Longueil, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Aalborg, , Denmark
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Aalborg SV, , Denmark
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Espergærde, , Denmark
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Greve, , Denmark
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Roslev, , Denmark
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Vaerloese, , Denmark
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Viborg, , Denmark
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Helsinki, , Finland
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Helsinki, , Finland
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Helsinki, , Finland
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Kerava, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Bourges, , France
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La Chapelle-sur-Erdre, , France
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La Roche-sur-Yon, , France
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Le Pradet, , France
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Murs Erigné, , France
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Saint-Avertin, , France
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Tours, , France
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Vihiers, , France
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Balve, , Germany
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Beckingen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Einbeck, , Germany
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Erfurt, , Germany
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Giengen an der Brenz, , Germany
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Hagen, , Germany
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Haigerloch, , Germany
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Hamburg, , Germany
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Kassel, , Germany
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Krefeld, , Germany
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Mahlberg, , Germany
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Messkirch, , Germany
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Reinfeld, , Germany
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Siegen, , Germany
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Wallerfing, , Germany
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Warendorf, , Germany
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Budapest, , Hungary
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Esztergom, , Hungary
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Miskolc, , Hungary
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Nyiregyháza, , Hungary
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Caserta, CE, Italy
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Cona, FE, Italy
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Florence, FI, Italy
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Pozzilli, IS, Italy
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Rozzano, MI, Italy
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Vimercate, MI, Italy
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Palermo, PA, Italy
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Padua, PD, Italy
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Pisa, PI, Italy
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Pisa, PI, Italy
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Casorate Primo, PV, Italy
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Pavia, PV, Italy
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Stradella, PV, Italy
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Mercato San Severino, SA, Italy
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Sassari, SS, Italy
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San Daniele del Friuli, UD, Italy
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Vibo Valentia, VV, Italy
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Daugavplis, , Latvia
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Kuldīga, , Latvia
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Ogre, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Alytus, , Lithuania
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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's-Hertogenbosch, , Netherlands
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Deurne, , Netherlands
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Ermelo, , Netherlands
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Hoogwoud, , Netherlands
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Leeuwarden, , Netherlands
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Losser, , Netherlands
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Oude Pekela, , Netherlands
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Poortvliet, , Netherlands
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Wamel, , Netherlands
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Ostrów Wielkopolski, , Poland
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Oława, , Poland
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Tarnów, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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S.-Petersburg, , Russia
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S.-Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Banská Bystrica, Slovak Republic, Slovakia
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Bratislava, Slovak Republic, Slovakia
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Nitra, Slovak Republic, Slovakia
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Prešov, Slovak Republic, Slovakia
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Dunajská Streda, , Slovakia
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Žilina, , Slovakia
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Seville, Andalusia, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Tàrrega, Catalonia, Spain
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Vic, Catalonia, Spain
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Begonte, Galicia, Spain
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Santiago de Compostela, Galicia, Spain
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Madrid, Madrid, Spain
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Alicante, Valencia, Spain
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Benidorm, Valencia, Spain
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Quart de Poblet, Valencia, Spain
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Hospitalet de Llbregat, , Spain
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Petrel, , Spain
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Riudecols, , Spain
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Boden, Sweden, Sweden
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Skellefteå, Sweden, Sweden
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Arvidsjaur, , Sweden
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Karlstad, , Sweden
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Kil, , Sweden
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Kristianstad, , Sweden
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Lund, , Sweden
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Taipei, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taichung, Taiwan ROC, Taiwan
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Tainan City, Taiwan ROC, Taiwan
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Changhua, , Taiwan
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Taichung County, , Taiwan
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Taipei, , Taiwan
Countries
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References
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Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.
Ruilope LM, Dukat A, Bohm M, Lacourciere Y, Gong J, Lefkowitz MP. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet. 2010 Apr 10;375(9722):1255-66. doi: 10.1016/S0140-6736(09)61966-8. Epub 2010 Mar 16.
Other Identifiers
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CLCZ696A2201
Identifier Type: -
Identifier Source: org_study_id
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