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completed
Phase 2

NCT01922089

Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

Sponsored by Novartis Pharmaceuticals

Summary

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers Exclusion Criteria: * Potassium \> 5.2 mmol/l; estimated glomerular filtration rate \< 30 ml/min/1.73 m2; systolic blood pressure \<100 mmHg or \> 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers Other protocol-defined inclusion/exclusion criteria may apply.

Locations (105)

Novartis Investigative Site

Anchorage, Alaska, United States

Novartis Investigative Site

Gilbert, Arizona, United States

Novartis Investigative Site

Tucson, Arizona, United States

Novartis Investigative Site

Anaheim, California, United States

Novartis Investigative Site

Torrance, California, United States

Novartis Investigative Site

Atlantis, Florida, United States

Novartis Investigative Site

Chiefland, Florida, United States

Novartis Investigative Site

Aurora, Illinois, United States

Novartis Investigative Site

Peoria, Illinois, United States

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Evansville, Indiana, United States

Novartis Investigative Site

Slidell, Louisiana, United States

Novartis Investigative Site

Minneapolis, Minnesota, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Buffalo, New York, United States

Novartis Investigative Site

Laurelton, New York, United States

Novartis Investigative Site

Marion, Ohio, United States

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Oak Ridge, Tennessee, United States

Novartis Investigative Site

Dallas, Texas, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

Livingston, Texas, United States

Novartis Investigative Site

Tacoma, Washington, United States

Novartis Investigative Site

Gabrovo, Bulgaria, Bulgaria

Novartis Investigative Site

Plovdiv, Bulgaria, Bulgaria

Novartis Investigative Site

Plovdiv, Bulgaria, Bulgaria

Novartis Investigative Site

Smolyan, Bulgaria, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Jyväskylä, Finland

Novartis Investigative Site

Tampere, Finland

Novartis Investigative Site

Bad Krozingen, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Buch, Germany

Novartis Investigative Site

Dietzenbach, Germany

Novartis Investigative Site

Ebersbach, Germany

Novartis Investigative Site

Frankfurt, Germany

Novartis Investigative Site

Göttingen, Germany

Novartis Investigative Site

Haßloch, Germany

Novartis Investigative Site

Huy / OT Anderbeck, Germany

Novartis Investigative Site

Ingelheim, Germany

Novartis Investigative Site

Kelkheim, Germany

Novartis Investigative Site

Kleve, Germany

Novartis Investigative Site

Leipzig, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Mühlheim, Germany

Novartis Investigative Site

Siegen, Germany

Novartis Investigative Site

Straubing, Germany

Novartis Investigative Site

Würzburg, Germany

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Debrecen, Hungary

Novartis Investigative Site

Mosonmagyaróvár, Hungary

Novartis Investigative Site

Nyiregyháza, Hungary

Novartis Investigative Site

Pécs, Hungary

Novartis Investigative Site

Székesfehérvár, Hungary

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Aosta, AO, Italy

Novartis Investigative Site

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

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Sassari, SS, Italy

Novartis Investigative Site

Vittorio Veneto, TV, Italy

Novartis Investigative Site

San Daniele del Friuli, UD, Italy

Novartis Investigative Site

San Juan, Puerto Rico

Novartis Investigative Site

Brezno, Slovak Republic, Slovakia

Novartis Investigative Site

Nitra, Slovak Republic, Slovakia

Novartis Investigative Site

Svidník, Slovak Republic, Slovakia

Novartis Investigative Site

Bratislava, Slovakia, Slovakia

Novartis Investigative Site

Bratislava, Slovakia, Slovakia

Novartis Investigative Site

Košice, Slovakia, Slovakia

Novartis Investigative Site

Lučenec, Slovakia, Slovakia

Novartis Investigative Site

Nové Zámky, Slovakia, Slovakia

Novartis Investigative Site

Trebišov, Slovakia, Slovakia

Novartis Investigative Site

Almería, Andalusia, Spain

Novartis Investigative Site

Málaga, Andalusia, Spain

Novartis Investigative Site

Sanlúcar de Barrameda, Andalusia, Spain

Novartis Investigative Site

Seville, Andalusia, Spain

Novartis Investigative Site

Villamartín, Cadiz, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

A Coruña, Galicia, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Istanbul, Turkey, Turkey (Türkiye)

Novartis Investigative Site

Haydarpasa/Istanbul, Turkey (Türkiye)

Novartis Investigative Site

Kocaeli, Turkey (Türkiye)

Novartis Investigative Site

Mersin, Turkey (Türkiye)

Novartis Investigative Site

Sivas, Turkey (Türkiye)

Novartis Investigative Site

Dorchester, Dorset, United Kingdom

Novartis Investigative Site

Saint Leonards-on-Sea, East Sussex, United Kingdom

Novartis Investigative Site

Oldham, Lancashire, United Kingdom

Novartis Investigative Site

Gateshead, Tyne and Wear, United Kingdom

Novartis Investigative Site

Bath, United Kingdom

Novartis Investigative Site

Bradford, United Kingdom

Novartis Investigative Site

Coventry, United Kingdom

Novartis Investigative Site

Harrow, United Kingdom

Novartis Investigative Site

Nuneaton, United Kingdom

Why you can trust this information
Registry sourcesclinicaltrials_gov
Source last updated10/15/2015
Clintriva indexed9/27/2026, 9:26:19 PM
Registry records1
Relationships needing review0

Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.

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Quick Facts
Start DateNov 1, 2013
CompletionAug 1, 2014
Enrollment0/498
CountryUnited States

Conditions

Heart Failure With Reduced Ejection Fraction
View on registry
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GDPR Controls Mapped HIPAA Safeguards Mapped NHS DSP Controls Mapped SOC 2 Controls Mapped

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