Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients
NCT ID: NCT01922089
Last Updated: 2015-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
498 participants
INTERVENTIONAL
2013-11-30
2014-08-31
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
QUADRUPLE
Study Groups
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LCZ696 Condensed
Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
LCZ696
LCZ696 50 mg/100 mg/200 mg bid
LCZ696 Conservative
Up-titration to LCZ696 200 mg bid over 6 weeks
LCZ696
LCZ696 50 mg/100 mg/200 mg bid
Interventions
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LCZ696
LCZ696 50 mg/100 mg/200 mg bid
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 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
Locations
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Novartis Investigative Site
Anchorage, Alaska, United States
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Gilbert, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Torrance, California, United States
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Atlantis, Florida, United States
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Chiefland, Florida, United States
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Aurora, Illinois, United States
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Peoria, Illinois, United States
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Evansville, Indiana, United States
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Slidell, Louisiana, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Buffalo, New York, United States
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Laurelton, New York, United States
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Marion, Ohio, United States
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Oak Ridge, Tennessee, 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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Livingston, Texas, United States
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Tacoma, Washington, United States
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Gabrovo, Bulgaria, Bulgaria
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Plovdiv, Bulgaria, Bulgaria
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Plovdiv, Bulgaria, Bulgaria
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Smolyan, Bulgaria, Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Jyväskylä, , Finland
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Tampere, , Finland
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Bad Krozingen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Buch, , Germany
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Dietzenbach, , Germany
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Ebersbach, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Haßloch, , Germany
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Huy / OT Anderbeck, , Germany
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Ingelheim, , Germany
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Kelkheim, , Germany
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Kleve, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Mainz, , Germany
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Mühlheim, , Germany
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Siegen, , Germany
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Straubing, , Germany
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Würzburg, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Mosonmagyaróvár, , Hungary
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Nyiregyháza, , Hungary
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Pécs, , Hungary
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Székesfehérvár, , Hungary
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Aosta, AO, Italy
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Cortona, AR, Italy
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Bergamo, BG, Italy
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Bologna, BO, Italy
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Cona, FE, Italy
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Albano Laziale, RM, Italy
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Roma, RM, Italy
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Sassari, SS, Italy
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Vittorio Veneto, TV, Italy
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San Daniele del Friuli, UD, Italy
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San Juan, , Puerto Rico
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Brezno, Slovak Republic, Slovakia
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Nitra, Slovak Republic, Slovakia
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Svidník, Slovak Republic, Slovakia
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Bratislava, Slovakia, Slovakia
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Bratislava, Slovakia, Slovakia
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Košice, Slovakia, Slovakia
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Lučenec, Slovakia, Slovakia
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Nové Zámky, Slovakia, Slovakia
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Trebišov, Slovakia, Slovakia
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Almería, Andalusia, Spain
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Málaga, Andalusia, Spain
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Sanlúcar de Barrameda, Andalusia, Spain
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Seville, Andalusia, Spain
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Villamartín, Cadiz, Spain
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Barcelona, Catalonia, Spain
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A Coruña, Galicia, Spain
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Madrid, Madrid, Spain
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Istanbul, Turkey, Turkey (Türkiye)
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Haydarpasa/Istanbul, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Sivas, , Turkey (Türkiye)
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Dorchester, Dorset, United Kingdom
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Saint Leonards-on-Sea, East Sussex, United Kingdom
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Oldham, Lancashire, United Kingdom
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Gateshead, Tyne and Wear, United Kingdom
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Bath, , United Kingdom
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Bradford, , United Kingdom
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Coventry, , United Kingdom
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Harrow, , United Kingdom
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Nuneaton, , United Kingdom
Countries
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References
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Senni M, McMurray JJV, Wachter R, McIntyre HF, Anand IS, Duino V, Sarkar A, Shi V, Charney A. Impact of systolic blood pressure on the safety and tolerability of initiating and up-titrating sacubitril/valsartan in patients with heart failure and reduced ejection fraction: insights from the TITRATION study. Eur J Heart Fail. 2018 Mar;20(3):491-500. doi: 10.1002/ejhf.1054. Epub 2017 Nov 22.
Senni M, McMurray JJ, Wachter R, McIntyre HF, Reyes A, Majercak I, Andreka P, Shehova-Yankova N, Anand I, Yilmaz MB, Gogia H, Martinez-Selles M, Fischer S, Zilahi Z, Cosmi F, Gelev V, Galve E, Gomez-Doblas JJ, Nociar J, Radomska M, Sokolova B, Volterrani M, Sarkar A, Reimund B, Chen F, Charney A. Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double-blind, randomized comparison of two uptitration regimens. Eur J Heart Fail. 2016 Sep;18(9):1193-202. doi: 10.1002/ejhf.548. Epub 2016 May 12.
Other Identifiers
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2013-001835-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCZ696B2228
Identifier Type: -
Identifier Source: org_study_id
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