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

Information source: Arbor Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Azilsartan Medoxomil (Drug); Losartan (Drug); Placebo for Azilsartan Medoxomil (Drug); Placebo for Losartan (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Arbor Pharmaceuticals, Inc.

Overall contact:
Djenane L Bennett, MS, RN, PMP, Phone: 470-235-2335, Email: dlbennett@arborpharma.com

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Blood Pressure

Secondary outcome: Change in blood Pressure relative to the comparator

Eligibility

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Djenane L Bennett, MS, RN, PMP, Phone: 470-235-2335, Email: dlbennett@arborpharma.com

Clinica de Nefrologia, Urologia y Enf. Cardiovasculares S A, Santa Fe S3000EPV, Argentina; Not yet recruiting

San Juan City Hospital - Dept of Pediatrics, San Juan 00918, Puerto Rico; Recruiting

University of Puerto Rico, Medical Sciences Campus, San Juan 00936-5067, Puerto Rico; Not yet recruiting

Hospital de Niños Dr. Ricardo Gutierrez, Ciudad Autonoma, Buenos Aires C1425EFD, Argentina; Not yet recruiting

Hospital Italiano, Ciudad Autonoma, Buenos Aires 1181, Argentina; Not yet recruiting

Hospital Universitario Austral, Pilar, Buenos Aires B1629ODT, Argentina; Not yet recruiting

Axis Clinical Trials, Los Angeles, California 90017, United States; Recruiting

Axis Clinical Trials, Los Angeles, California 90036, United States; Recruiting

Neufeld Medical Group, Los Angeles, California 90048, United States; Recruiting

Harbor UCLA Medical Center, Torrance, California 90509, United States; Recruiting

Alfred I. duPont Hospital for Children of the Nemours Foundation, Wilmington, Delaware 19803, United States; Not yet recruiting

Miami Children's Hospital, Miami, Florida 33155, United States; Not yet recruiting

University of Miami/Jackson Memorial Hospital, Miami, Florida 33136, United States; Not yet recruiting

University of South Florida Diabetes Center, St. Petersburg, Florida 33701, United States; Recruiting

LCS Clinical Research Unit, Johannesburg, Gauteng 2021, South Africa; Not yet recruiting

Soweto Clinical Trial Centre, Soweto, Gauteng 1818, South Africa; Not yet recruiting

North Georgia Clinical Research Center, Dalton, Georgia 30721, United States; Recruiting

University of Louisville, Louisville, Kentucky 40202, United States; Not yet recruiting

Bocking, F, Pietermaritzburg, KwaZulu-Natal 3201, South Africa; Not yet recruiting

David M. Headley, MD PA, Port Gibson, Mississippi 39150, United States; Recruiting

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Not yet recruiting

Mount Sinai PRIME, New York, New York 10029, United States; Recruiting

Kelfkens, Y, Potchefstroom, North West 2531, South Africa; Not yet recruiting

Promedica Toledo Children's Hospital, Toledo, Ohio 43606, United States; Not yet recruiting

Oregon Health & Science University, Portland, Oregon 97227, United States; Not yet recruiting

Medical University of South Carolina (MUSC), Charleston, South Carolina 29425, United States; Not yet recruiting

Southeast Texas Clinical Research Center, Beaumont, Texas 77701, United States; Recruiting

Texas Children's Heart Center, Houston, Texas 77030, United States; Not yet recruiting

Texas Children's Hospital -Research Resource Office, Houston, Texas 77030, United States; Not yet recruiting

Centro Infantil del Riñon, San Miguel de Tucuman, Tucuman T4000ICP, Argentina; Not yet recruiting

Ericksen Research & Development, LLC, Clinton, Utah 84015, United States; Recruiting

University of Utah, Salt Lake City, Utah 84108, United States; Not yet recruiting

Virginia Commonwealth University Health System, Richmond, Virginia 23298, United States; Not yet recruiting

Seattle Children's Hospital, Seattle, Washington 98105, United States; Not yet recruiting

CAMC Health Education and Research Institute, Charleston, West Virginia 25304, United States; Recruiting

Groote Schuur Hospital E13 Renal Unit, Cape Town, Western Cape 7925, South Africa; Not yet recruiting

Clinical Projects Research SA (PTY) LTD, Worcester, Western Cape 6850, South Africa; Not yet recruiting

Additional Information

Starting date: December 2014
Last updated: February 24, 2015

Page last updated: August 23, 2015

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