Efficacy and Safety of LCZ696A in Patients With Essential Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:September 2007
End Date:July 2008

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A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension

This study was a dose-ranging efficiacy study in patients with essential hypertension to
assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and
placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to
placebo.


Inclusion Criteria:

- Male or females from 18 up to and including 75 years

- Patients with mild-to-moderate uncomplicated essential hypertension, untreated or
currently taking antihypertensive therapy (monotherapy or combination therapy of 2
drugs; therapy with a fixed dose combination of two active substances represents 2
drugs)

- Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit
(Visit 3) and the 2 preceding visits (Visits 1 and 2).

- Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and
a msDBP> 95 mmHg at baseline (Visit 3);

Exclusion Criteria:

- Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)

- History of angioedema, drug-related or otherwise, as reported by the patient

- Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)

- History or evidence of a secondary form of hypertension, such as renal parenchymal
hypertension, renovascular hypertension, coarctation of the aorta, primary
hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or
bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.

- History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic
heart disease, surgical or percutaneous arterial intervention of any kind (coronary,
carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid
artery stenosis, aortic aneurysm or peripheral arterial disease
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Richmond, Virginia 23249
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Augusta, Georgia 30904
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Brooklyn Center, Minnesota 55430
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Chandler, Arizona 85224
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Charleston, West Virginia 25304
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Chicago, Illinois 60612
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Cincinnati, Ohio 45229
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Dallas, Texas 75216
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Fair Oaks, California 95628
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Houston, Texas 77030
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Jacksonville, Florida 32216
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Lake Jackson, Texas 77566
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Long Beach, California 90813
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Muscle Shoals, Alabama 35662
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Orangevale, California 95662
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Pembroke Pines, Florida 33024
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Pensacola, Florida 32504
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Peoria, Illinois 61615
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Royal Oak, Michigan 48073
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Santa Ana, California 92705
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Simpsonville, South Carolina 29681
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St. Peters, Missouri 63376
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Stockton, California 95204
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Toms River, New Jersey 08755
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Trenton, New Jersey 08629
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Tustin, California 92780
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