Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2013
End Date:August 2014

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A Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients Comparing Two Titration Regimens

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.


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.
We found this trial at
25
sites
Anaheim, California 92801
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Anchorage, Alaska 99508
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Atlantis, Florida 33462
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Aurora, Illinois 60504
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Buffalo, New York 14215
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Chiefland, Florida 32626
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Dallas, Texas 75216
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Evansville, Indiana 47713
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Evansville, IN
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Gabrovo,
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Gilbert, Arizona 85234
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Gilbert, AZ
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Laurelton, New York 11422
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Laurelton, NY
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Livingston, Texas 77351
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Livingston, TX
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Marion, Ohio 43302
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Marion, OH
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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Oak Ridge, Tennessee 37830
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Peoria, Illinois 61615
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Peoria, IL
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Slidell, Louisiana 70458
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St. Louis, Missouri 63110
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Tacoma, Washington 98405
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Tacoma, WA
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Torrance, California 90502
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Torrance, CA
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Tucson, Arizona 85745
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Tucson, AZ
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