Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2013
End Date:August 2014

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A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in
essential hypertensive patients not adequately responsive to olmesartan


Inclusion Criteria:

- patients with mild to moderate hypertension, untreated or currently taking
antihypertensive therapy

- treated patients (using antihypertensive drugs within 4 weeks prior to first visit)
must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4
weeks run-in epoch

- untreated patients (either newly diagnosed or those patients with a history of
hypertension but have not been taking any antihypertensive drugs for at least 4 weeks
prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at
screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and <
180 mmHg after 4 weeks run-in epoch

- patients must successfully complete ABPM and pass technical requirements to be
qualified for randomization

Exclusion Criteria:

- Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg
and/or msSBP ≥ 180 mmHg)

- History of angioedema, drug-related or otherwise

- History or evidence of a secondary form of hypertension, including but not limited to
any of the following: renal parenchymal hypertension, renovascular hypertension
(unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary
hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease
(PKD), drug-induced hypertension

- Patients who previously entered a LCZ696 study and had been randomized or enrolled to
receive active drug treatment
We found this trial at
23
sites
Atlanta, Georgia 30322
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Belzoni, Mississippi 39038
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Birmingham, Alabama 35209
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Birmingham, AL
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Caba, Buenos Aires
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Caba,
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Chicago, Illinois 60612
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Chicago, IL
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Chicago, Illinois 60612
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Chicago, IL
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Conyers, Georgia 30013
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Conyers, GA
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Denver, Colorado 80262
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Denver, CO
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Edina, Minnesota 55435
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Edina, MN
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Fair Oaks, California 95628
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Fair Oaks, CA
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Hawaiian Gardens, California 90716
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Hawaiian Gardens, CA
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Jackson, Mississippi 39209
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Jackson, MS
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Long Beach, California 90813
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Long Beach, CA
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Los Angeles, California 90095
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Los Angeles, CA
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Orangevale, California 95662
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Orangevale, CA
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Oregon City, Oregon 97045
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Oregon City, OR
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Portland, OR
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Richmond, Virginia 23249
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Richmond, VA
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Topeka, Kansas 66606
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Topeka, KS
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Varnville, South Carolina 29944
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Varnville, SC
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Westlake Village, California 91361
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Westlake Village, CA
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