An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:6 - 18
Updated:2/11/2017
Start Date:December 2014
End Date:August 2018
Contact:Steve Caras, MD
Email:scaras@arborpharma.com
Phone:470 235-2327

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A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension

The purpose of the study is to evaluate the efficacy and safety of the study drug relative
to an active comparator losartan which the same class of drug and is approved for use in the
pediatric population aged 6 years and older. Approximately 260 subjects will participate in
a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind,
randomized placebo-controlled withdrawal phase. This study also includes a 44-week,
open-label extension (OL Phase) in which all subjects will receive AZM and other
antihypertensive medications (if needed) in order to reach an optimal blood pressure. Blood
pressure will be assessed in the clinic throughout the study, and subjects may also
participate in a 24-hour ambulatory blood pressure monitoring (ABPM) procedure at baseline,
at the end of the DB Phase and at the end of the OL Phase.


Inclusion Criteria:

- The subject has hypertension (primary or secondary) defined as clinic Seated
Diastolic BP ≥95th percentile (by age, gender, and height) or ≥90th percentile (by
age, gender, height) if chronic renal disease, diabetes, heart failure or
hypertensive target organ damage is present

1. If currently treated: The subject has a documented historical diagnosis of
hypertension AND a post-washout clinic Seated Diastolic BP meeting the above
criteria on Day -1 (or Day 1 for subjects not participating in Ambulatory Blood
Pressure Monitoring)

2. If currently untreated: The subject has elevated Seated Diastolic BP meeting the
above criteria on 3 separate occasions before Randomization, including on Day -1
(or Day 1 for subjects not participating in Ambulatory Blood Pressure
Monitoring)

- The subject is male or female and aged 6 to <18 years at Baseline and weighs at least
25 kg

- The subject agrees to continue their previously implemented nonpharmacological life
style modifications if begun prior to Screening. Note: For subjects participating in
a weight loss program, the weight maintenance

Exclusion Criteria:

- The subject has a clinic Seated Diastolic BP greater than 15 mm Hg and/or Seated
Diastolic BP greater than 10 mm Hg above the 99th percentile for age, gender, and
height as confirmed by the average (arithmetic mean) of 3 serial clinic seated BP
measurements at Screening/Visit 1

- The subject has a diagnosis of malignant or accelerated hypertension

- The subject is currently treated with more than 2 antihypertensive agents

- The subject or parent/legal guardian is not willing for the subject's previous
antihypertensive medications to be stopped

- The subject has participated in the intensive, active weight-loss phase of a
weight-loss program within 30 days prior to Screening/Visit 1

- The subject has any of the following: severe renal impairment (eGFR <30 mL/min/1.73
m2 by the Schwartz formula); is currently undergoing dialysis treatment; renovascular
disease affecting both kidneys or a solitary kidney; severe nephrotic syndrome not in
remission; or serum albumin <2.5 g/dL

- The subject has a history or clinical manifestations of severe cardiovascular,
hepato-biliary, gastrointestinal, endocrine-metabolic (e.g., hyperthyroidism,
Cushing's syndrome), hematologic, immunologic, genito-urinary, or psychiatric
disease, cancer, and/or any conditions that would interfere with the health status of
the subject through study participation, or would jeopardize study integrity in the
opinion of the investigator

- The subject is suffering from uncorrected coarctation of the aorta, or
hemodynamically significant left ventricular outflow tract obstruction due to eg,
aortic valvular disease, or is likely to undergo a procedure known to affect blood
pressure (eg, repair of arterial anomalies) during the course of the study

- The subject is poorly controlled diabetic defined as having a glycosylated hemoglobin
value >8.5% at Screening/Visit 1

- The subject has hyperkalemia as defined by the central laboratory's normal reference
range or any pertinent electrolyte disorders at Screening/Visit
We found this trial at
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Anaheim, California 92805
Phone: 714-493-7258
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1611 Northwest 12th Avenue
Miami, Florida 33136
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3181 Southwest Sam Jackson Park Road
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503 494-8311
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Beaumont, Texas 77702
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Ciudad Autonoma, Buenos Aires
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Clinton, Utah 84015
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Houston, Texas 77030
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500 S Preston St
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Miami, Florida 33186
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922 Southwest 82nd Avenue
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Miami, Florida 33176
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