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

Description

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.

Study Start Date

December 2014

Estimated Completion Date

August 2018

Interventions

  • Drug: Losartan
  • Drug: Placebo for Azilsartan Medoxomil
  • Drug: Azilsartan Medoxomil
  • Drug: Placebo for Losartan

Specialties

  • Cardiology: Clinical Pharmacology,Hypertension
  • Internal Medicine: Cardiology
  • Physician Assistant: Cardiology,Clinical Pharmacology

MeSH Terms

  • Azilsartan Medoxomil
  • Hypertension

Study ID

Arbor Pharmaceuticals, Inc. -- AR14.001

Status

Unknown

Trial ID

NCT02235909

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

260

Sponsor

Arbor Pharmaceuticals, Inc.

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

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (27)

Study Location Distance Name Phone Email
Mount Sinai PRIME - Lake Success, New York 46.8 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 47.6 miles None None None
Alfred I duPont Hospital for Children of the Nemours Foundation - Wilmington, Delaware 155.5 miles None None None
Virginia Commonwealth University Health System - Richmond, Virginia 338.8 miles None None None
CAMC Health Education and Research Institute - Charleston, West Virginia 487.0 miles None None None
Promedica Toledo Childrens Hospital - Toledo, Ohio 538.2 miles None None None
Medical University of South Carolina MUSC - Charleston, South Carolina 691.2 miles None None None
University of Louisville - Louisville, Kentucky 696.1 miles None None None
North Georgia Clinical Research Center - Dalton, Georgia 776.9 miles None None None
University of South Florida Diabetes Center - St. Petersburg, Florida 1,073.3 miles None None None
University of MiamiJackson Memorial Hospital - Miami, Florida 1,141.0 miles None None None
JDH Medical Group LLC - Miami, Florida 1,141.9 miles None None None
Miami Childrens Hospital - Miami, Florida 1,146.3 miles None None None
Trials Clinical Research of Homestead - Homestead, Florida 1,167.1 miles None None None
David M Headley MD PA - Port Gibson, Mississippi 1,173.1 miles None None None
Cutting Edge Research Group INC - Oklahoma City, Oklahoma 1,373.7 miles None None None
Southeast Texas Clinical Research Center - Beaumont, Texas 1,399.2 miles None None None
Baylor College of Medicine - Houston, Texas 1,475.7 miles None None None
Texas Childrens Hospital Research Resource Office - Houston, Texas 1,475.7 miles None None None
Texas Childrens Heart Center - Houston, Texas 1,475.7 miles None None None
University of Utah - Salt Lake City, Utah 2,000.1 miles None None None
Ericksen Research Development LLC - Clinton, Utah 2,005.0 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,424.5 miles None None None
Oregon Health Science University - Portland, Oregon 2,466.8 miles None None None
Advanced Research Center INC - Anaheim, California 2,478.2 miles None None None
Neufeld Medical Group - Los Angeles, California 2,495.4 miles None None None
Harbor UCLA Medical Center - Torrance, California 2,499.6 miles None None None

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