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.
We found this trial at
180
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Bartlesville, Oklahoma 74006
735
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from 43215
Bartlesville, OK
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Albuquerque, New Mexico 87108
1330
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Albuquerque, New Mexico 87108
1330
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Alexandria, Louisiana 71301
797
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Aliquippa, Pennsylvania 15001
152
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Aliquippa, PA
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Amarillo, Texas 79106
1081
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Amarillo, TX
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Anaheim, California 92801
1962
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Anaheim, CA
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Anchorage, Alaska 99508
3103
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Anchorage, AK
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Ann Arbor, Michigan 48109
164
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Ann Arbor, MI
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Arlington, Texas 76012
928
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Arlington, TX
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Asheboro, North Carolina 27204
341
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Asheville, North Carolina 28803
304
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Ayer, Massachusetts 01432
619
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Baltimore, Maryland 21287
345
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Beaumont, Texas 77702
926
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Beaumont, TX
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Beaumont, Texas 77702
926
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Beaver, Pennsylvania 15009
151
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Beaver, PA
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Bellflower, California 90706
1970
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Beltsville, Maryland 20705
332
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Berkley, California 94705
2095
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Biddeford, Maine 04005
691
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Birmingham, Alabama 35209
495
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Birmingham, Alabama 35209
495
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Birmingham, Alabama 35209
495
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Birmingham, Alabama 35209
495
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Boston, Massachusetts 02118
643
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Boston, MA
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Boston, Massachusetts 02118
643
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Boston, MA
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Boynton Beach, Florida 33437
943
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Brownsville, Texas 78520
1278
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Caba, Buenos Aires
5386
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Caba,
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Cadiz, Ohio 43907
109
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Canton, Ohio 44718
103
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Cary, North Carolina 27511
370
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Charleston, South Carolina 29407
525
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Chicago, Illinois 60612
277
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Chicago, Illinois 60612
277
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Cincinnati, Ohio 45229
95
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Cincinnati, Ohio 45229
95
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Cleveland, Ohio 44109
123
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Columbia, Maryland 21044
331
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Columbus, Ohio 43205
3
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Cordtlandt Manor, New York 10567
487
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Covington, Georgia 30014
442
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Covington, Louisiana 70433
767
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Dallas, Texas 75216
914
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Dallas, Texas 75216
914
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Dallas, Texas 75216
914
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Dallas, Texas 75216
914
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Davie, Florida 33324
970
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Decatur, Georgia 30030
433
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Denver, Colorado 80262
1159
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Denver, Colorado 80262
1159
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Des Moines, Iowa 50314
565
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Detroit, Michigan 48202
165
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Elizabeth, New Jersey 07202
466
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Fort Lauderdale, Florida 33313
967
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Fredericksburg, Virginia 22401
319
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Fremont, Nebraska 68025
712
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Gainesville, Florida 32608
716
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Gilbert, Arizona 85234
1647
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Grand Island, Nebraska 68803
807
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Grapevine, Texas 76051
918
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Greensboro, North Carolina 27401
322
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Hamilton, New Jersey 08690
442
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Haverhill, Massachusetts 01830
650
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Honolulu, Hawaii 96813
4501
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Honolulu, Hawaii 96813
4501
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Houston, Texas 77030
995
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, Texas 77030
995
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Houston, Texas 77030
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Houston, Texas 77030
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Huntsville, Alabama 35801
409
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Jacksonville, Florida 32216
673
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Jacksonville, Florida 32216
673
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Jacksonville, Florida 32216
673
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Kingwood, Texas 77339
970
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Lafayette, Louisiana 70501
840
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Lafayette, Louisiana 70501
840
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Lakeland, Florida 33805
822
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Lapeer, Michigan 48446
213
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Laurelton, New York 11422
490
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Layton, Utah 84041
1515
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Leesburg, Florida 34748
773
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Little Rock, Arkansas 72204
627
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Little Rock, Arkansas 72204
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Little Rock, Arkansas 72204
627
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Little Rock, Arkansas 72204
627
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Livingston, Texas 77351
925
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Loma Linda, California 92354
1919
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Loma Linda, California 92354
1919
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Los Angeles, California 90095
1982
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Los Angeles, California 90095
1982
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Lufkin, Texas 75904
885
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Madison, Wisconsin 53705
395
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Marion, Ohio 43302
43
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Mather, California 95655
1970
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