Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in 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:March 2009
End Date:October 2015

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A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV).

The study will evaluate the efficacy and safety of both aliskiren monotherapy and
aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity
and mortality in patients with chronic heart failure (NYHA Class II - IV.


Inclusion Criteria:

- Patients with a diagnosis of chronic heart failure (NYHA Class II - IV):

- LVEF ≤ 35% at visit 1. (local measurement, measured within the past 6 months
assessed by echocardiogram, MUGA, CT scan, MRI or ventricular angiography)

- Elevated BNP at visit 1: BNP ≥ 150 pg/ml (according to local measurement).

- BNP ≥ 100 pg/ml (according to local measurement) and unplanned hospitalization
with HF within the last 12 months prior visit 1.

- Patients must be treated with an ACE inhibitor at a stable dose (enalapril 10 mg
daily at least or any other ACE inhibitor, e.g. ramipril, quinapril, lisinopril,
fosinopril, perindopril, trandolapril; based on equivalent doses as described in the
dose equivalence guidance table of ACEi's) for at least 4 weeks prior to visit 1

Exclusion Criteria:

- History of hypersensitivity to any of the study drugs including history or allergy to
ACEi's as well as known or suspected contraindications to the study drugs or previous
history of intolerance to high doses of ACEi's during up titration process.

- Patients treated concomitantly with both ARB and aldosterone antagonist in addition
to study drug at visit 1.

- Current acute decompensated HF.

- Symptomatic hypotension and/or less than 95 mmHg SBP at visit 1 and/or less than 90
mmHg at visit 4.

- Renal disease likely to be life threatening or eGFR < 40 ml/min/1.73m2 as measured by
the MDRD formula at visit 1 and eGFR < 35 ml/min/1.73m2 as measured by the MDRD
formula at visit 4 or decrease of eGFR of more than 25% from visit 1 to visit 4
(according to local laboratory measurement).

- Serum potassium ≥ 5.0 mmol/L at visit 1 or ≥ 5.2 mmol/L at visit 4 (according to
local laboratory measurement).

- Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major
vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty,
within the past 3 months prior to visit 1.

- Coronary or carotid artery disease likely to require surgical or percutaneous
intervention within the 6 months after visit 1.

- Right heart failure due to severe pulmonary disease

- Patients with diabetes mellitus

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
67
sites
Metairie, Louisiana 70006
688
mi
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Metairie, LA
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Athens, Georgia 30606
846
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Athens, GA
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Auburn, Maine 04210
1497
mi
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Auburn, ME
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Augusta, Georgia 30904
934
mi
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Augusta, GA
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Bahia Blanca, Buenos Aires
5746
mi
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Bahia Blanca,
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Beverly Hills, California 90211
1175
mi
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Beverly Hills, CA
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Boynton Beach, Florida 33437
1288
mi
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Boynton Beach, FL
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Charleston, South Carolina 29407
1063
mi
from
Charleston, SC
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Dallas, Texas 75216
353
mi
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Dallas, TX
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Daytona Beach, Florida 32117
1127
mi
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Daytona Beach, FL
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Denver, Colorado 80262
407
mi
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Denver, CO
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Durham, North Carolina 27710
1048
mi
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Durham, NC
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Elmer, New Jersey 08318
1225
mi
from
Elmer, NJ
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Everett, Washington 98208
1410
mi
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Everett, WA
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Fort Lauderdale, Florida 33313
1302
mi
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Fort Lauderdale, FL
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Fort Lauderdale, Florida 33313
1302
mi
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Fort Lauderdale, FL
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French Camp, California 95231
1276
mi
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French Camp, CA
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Germantown, Tennessee 38138
481
mi
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Germantown, TN
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Gillespie, Illinois 62033
443
mi
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Gillespie, IL
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Hollywood, Florida 33021
1310
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Hollywood, FL
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Hot Springs, Arkansas 71913
347
mi
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Hot Springs, AR
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Houston, Texas 77030
572
mi
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Houston, TX
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Houston, Texas 77030
572
mi
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Houston, TX
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Houston, Texas 77030
572
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Houston, TX
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Huntsville, Alabama 35801
661
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Huntsville, AL
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Inglewood, California 90301
1176
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Inglewood, CA
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Jacksonville Beach, Florida 32050
1055
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Jacksonville Beach, FL
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Kirkland, Washington 98034
1407
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Kirkland, WA
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Laurelton, New York 11422
1300
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Laurelton, NY
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Lincoln, Nebraska 68506
218
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Lincoln, NE
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Little Rock, Arkansas 72204
368
mi
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Little Rock, AR
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Little Rock, Arkansas 72204
368
mi
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Little Rock, AR
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Little Rock, Arkansas 72204
368
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Little Rock, AR
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Little Rock, Arkansas 72204
368
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Little Rock, AR
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Littleton, Colorado 80120
407
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Littleton, CO
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Los Angeles, California 90095
1177
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Los Angeles, CA
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Marion, Ohio 43302
810
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Marion, OH
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Memphis, Tennessee 38120
478
mi
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Memphis, TN
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Miami Lakes, Florida 33014
1309
mi
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Miami Lakes, FL
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Mobile, Alabama 36693
740
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Mobile, AL
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Mobile, Alabama 36693
740
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Mobile, AL
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Mobile, Alabama 36693
740
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Mobile, AL
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Modesto, California 95355
1263
mi
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Modesto, CA
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Nashville, Tennessee 37205
615
mi
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Nashville, TN
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Nashville, Tennessee 37205
615
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Nashville, TN
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New Orleans, Louisiana 70115
697
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New Orleans, LA
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Northridge, California 91325
1179
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Northridge, CA
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Omaha, Nebraska 68144
257
mi
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Omaha, NE
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Orlando, Florida 32806
1144
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Orlando, FL
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Orlando, Florida 32806
1144
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Pine Bluff, Arkansas 71603
406
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Pine Bluff, AR
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Sacramento, California 95825
1278
mi
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Sacramento, CA
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San Diego, California 92123
1138
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San Diego, CA
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Santa Monica, California 90404
1181
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Santa Monica, CA
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Searcy, Arkansas 72143
379
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Searcy, Arkansas 72143
379
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Slidell, Louisiana 70458
691
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Southfield, Michigan 48075
835
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St. Louis, Missouri 63110
415
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Stony Brook, New York 11794
1333
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Topeka, Kansas 66606
145
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Topeka, KS
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Tucson, Arizona 85745
841
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Tucson, Arizona 85745
841
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Varnville, South Carolina 29944
1001
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Wellington, Florida 33449
1281
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Wellington, FL
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Westlake Village, California 91361
1197
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Wiliamsville, New York 14221
1065
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Wiliamsville, NY
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