8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:April 2012
End Date:December 2012
Contact:Novartis Pharmaceuticals
Phone:+1(862)778-8300

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An 8-week Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Oral Aliskiren 300 mg Once Daily Under Light Meal Versus Fasted Condition in Patients With Hypertension


The purpose of this study is to evaluate the effect of food on aliskiren's efficacy,
pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light
meal versus fasted conditions.


Inclusion Criteria:

- Male or female outpatients age ≥ 18 years old. A higher age limit will be considered
for countries based on their local regulations ( e.g., Taiwan, ≥ 20 years)

- Patients with essential hypertension, untreated or currently taking
antihypertensive therapy (monotherapy or combination therapy).

- Patients must have an office BP ≥ 140/90 mmHg and < 180/110mmHg at the
randomization visit and the preceding visit

- Patients must have an absolute difference of ≤ 10 mmHg in both their msSBP and
their msDBP between the randomization visit and the preceding visit

Exclusion Criteria:

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

- 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 (PKD).

- Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) >
8%

- Any surgical or medical condition which may significantly alter the absorption,
distribution, metabolism or excretion of aliskiren, including but not limited to, any
of the following: history of major gastrointestinal tract surgery such as
gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or
gastric banding, currently active, or active inflammatory bowel syndrome within 12
months prior to Visit 1, regarded as clinically meaningful by the investigator.

Other protocol-defined inclusion/exclusion criteria may apply.

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Blue Bell, Pennsylvania 19422
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Abingdon, Virginia 24210
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Beach Grove, Indiana 46107
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Chicago, Illinois 60637
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Cincinatti, Ohio 45219
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Dallas, Texas 75216
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High Point, North Carolina 27262
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Knoxville, Tennessee 37934
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Los Angeles, California 90095
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Louisville, Kentucky 40202
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Miami, Florida 33136
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New Orleans, Louisiana 70115
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Oklahoma City, Oklahoma 73104
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Overland Park, Kansas 66210
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Portland, Oregon 97228
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Rochester, Minnesota 55905
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Salt Lake City, Utah 84103
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Spokane, Washington 99202
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St Louis, Missouri 63104
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Tupelo, Mississippi 38801
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Tupelo, MS
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