This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2009
End Date:May 2014

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A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity
and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).


Inclusion Criteria:

- Patients must give written informed consent before any assessment is performed.

- Outpatients ≥ 18 years of age, male or female.

- Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF
=< 35%) and elevated BNP.

- Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d
or equivalent for at least 4 weeks.

- Patients must be treated with a β-blocker, unless contraindicated or not tolerated,
at a stable dose for at least 4 weeks.

Exclusion Criteria:

- Use of other investigational drugs at the time of enrollment, or within 30 days or 5
half-lives of enrollment, whichever is longer.

- History of hypersensitivity or allergy to any of the study drugs, drugs of similar
chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected
contraindications to the study drugs.

- Previous history of intolerance to recommended target doses of ACEIs or ARBs

- Known history of angioedema.

- Requirement of treatment with both ACEIs and ARBs.

- Current acute decompensated HF (exacerbation of chronic HF manifested by signs and
symptoms that may require intravenous therapy).

- Symptomatic hypotension and/or a SBP < 100 mmHg.

- Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula

- Serum potassium > 5.2 mmol/L.

Other protocol-defined inclusion/exclusion criteria may apply.
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180
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Jacksonville, Florida 32216
2135
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Albuquerque, New Mexico 87108
653
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Albuquerque, New Mexico 87108
653
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Alexandria, Louisiana 71301
1494
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Aliquippa, Pennsylvania 15001
2105
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Amarillo, Texas 79106
918
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Anaheim, California 92801
16
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Anchorage, Alaska 99508
2343
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Ann Arbor, Michigan 48109
1932
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Arlington, Texas 76012
1205
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Asheboro, North Carolina 27204
2153
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Asheville, North Carolina 28803
2003
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Ayer, Massachusetts 01432
2550
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Baltimore, Maryland 21287
2302
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Bartlesville, Oklahoma 74006
1251
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Beaumont, Texas 77702
1421
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Beaumont, Texas 77702
1421
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Beaver, Pennsylvania 15009
2103
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Bellflower, California 90706
14
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Beltsville, Maryland 20705
2287
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Berkley, California 94705
352
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Biddeford, Maine 04005
2605
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Birmingham, Alabama 35209
1785
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Birmingham, Alabama 35209
1785
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Birmingham, Alabama 35209
1785
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Birmingham, Alabama 35209
1785
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Boston, Massachusetts 02118
2578
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Boston, Massachusetts 02118
2578
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Boynton Beach, Florida 33437
2304
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Brownsville, Texas 78520
1340
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Caba, Buenos Aires
6113
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Cadiz, Ohio 43907
2066
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Canton, Ohio 44718
2044
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Cary, North Carolina 27511
2210
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Charleston, South Carolina 29407
2184
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Chicago, Illinois 60612
1726
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Chicago, Illinois 60612
1726
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Cincinnati, Ohio 45229
1881
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Cincinnati, Ohio 45229
1881
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Cleveland, Ohio 44109
2031
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Columbia, Maryland 21044
2287
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Columbus, Ohio 43205
1962
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Cordtlandt Manor, New York 10567
2437
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Covington, Georgia 30014
1951
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Covington, Louisiana 70433
1644
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Dallas, Texas 75216
1225
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Dallas, Texas 75216
1225
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Dallas, Texas 75216
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Dallas, Texas 75216
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Davie, Florida 33324
2308
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Decatur, Georgia 30030
1924
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Denver, Colorado 80262
820
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Denver, Colorado 80262
820
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Des Moines, Iowa 50314
1422
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Detroit, Michigan 48202
1965
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Elizabeth, New Jersey 07202
2422
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Fort Lauderdale, Florida 33313
2309
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Fredericksburg, Virginia 22401
2261
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Fremont, Nebraska 68025
1276
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Gainesville, Florida 32608
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Gilbert, Arizona 85234
363
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Grand Island, Nebraska 68803
1174
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Grapevine, Texas 76051
1206
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Greensboro, North Carolina 27401
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Hamilton, New Jersey 08690
2400
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Haverhill, Massachusetts 01830
2577
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Honolulu, Hawaii 96813
2573
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Honolulu, Hawaii 96813
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Houston, Texas 77030
1357
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Huntsville, Alabama 35801
1786
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Jacksonville, Florida 32216
2135
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Jacksonville, Florida 32216
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Kingwood, Texas 77339
1360
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Lafayette, Louisiana 70501
1540
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Lafayette, Louisiana 70501
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Lakeland, Florida 33805
2163
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Lapeer, Michigan 48446
1958
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Laurelton, New York 11422
2446
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Layton, Utah 84041
584
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Leesburg, Florida 34748
2149
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Little Rock, Arkansas 72204
1458
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Livingston, Texas 77351
1363
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Loma Linda, California 92354
43
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Loma Linda, California 92354
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Los Angeles, California 90095
25
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Los Angeles, California 90095
25
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Lufkin, Texas 75904
1363
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Madison, Wisconsin 53705
1653
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Marion, Ohio 43302
1955
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Mather, California 95655
282
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