Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:60 - Any
Updated:4/21/2016
Start Date:December 2012
End Date:April 2015

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A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension

To examine the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic
Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial
stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened
pulse pressure (PP).


Inclusion Criteria:

1. Male and female patients ≥ 60 years of age.

2. Patients with essential hypertension, untreated or currently taking antihypertensive
therapy.

3. Untreated patients must have an office msSBP ≥150 mmHg and <180 mmHg at Visit 101 and
Visit 201 if they are newly diagnosed or have not been treated with antihypertensive
drugs for the 4 weeks prior to Visit 1.

4. Treated patients must have an office msSBP ≥140 mmHg and <180 mmHg at Visit 102 (or
Visit 103) and msSBP ≥150 mmHg and <180 mmHg at Visit 201 if they have been treated
with antihypertensive drugs for the 4 weeks prior to Visit 1.

5. All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is
defined as msSBP- msDBP.

6. Patients must have a difference in msSBP within +/-15 mmHg between Visit 201
(randomization) and the visit immediately prior to Visit 201.

Exclusion Criteria:

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

2. History of angioedema, drug-related or otherwise.

3. 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,
and drug-induced hypertension.

4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any
history of stroke.

5. History of myocardial infarction, coronary bypass surgery or any percutaneous
coronary intervention (PCI) during the 12 months prior to Visit 1.

6. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit
1, or active atrial fibrillation or atrial flutter on the ECG at screening.

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
12
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Buffalo, New York 14215
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Baltimore, Maryland 21287
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Belzoni, Mississippi 39038
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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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Cincinnati, Ohio 45229
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Cincinnati, OH
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Clearwater, Florida 33756
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Clearwater, FL
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Houston, Texas 77030
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Houston, TX
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Jackson, Mississippi 39209
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Jackson, MS
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Lake Jackson, Texas 77566
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Lake Jackson, TX
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Pasadena, Texas 77504
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Pasadena, TX
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St. Louis, Missouri 63110
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St. Louis, MO
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