Last updated on February 2017

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


Brief description of study

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 Study Identifier: NCT02235909

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Patrick Walsh, MD

Advanced Research Center, INC
Anaheim, CA United States
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Enrique Hanabergh, MD

JDH Medical Group LLC
Miami, FL United States
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Wacharee (Mimi) Seeherunvong, MD

University of Miami/Jackson Memorial Hospital
Miami, FL United States
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Serman Ojeda Gill, MD

Medical Research Center of Miami II, Inc.
Miami, FL United States
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Maria Delgado, MD

Advanced Clinical Research
Miami, FL United States
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Valerie Panzarino, MD

University of South Florida Diabetes Center
St. Petersburg, FL United States
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John Lentz, MD

Georgia Clinical Research
Snellville, GA United States
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Stephanie Kong, MD

Zoe Center for Pediatrics
Thomaston, GA United States
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Janice Sullivan, MD

University of Louisville
Louisville, KY United States
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David Headley, MD

David M. Headley, MD PA
Port Gibson, MS United States
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Hilary Hotchkiss, MD

Mount Sinai PRIME
Lake Success, NY United States
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Jeffrey Blumer, MD

Promedica Toledo Children's Hospital
Toledo, OH United States
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Willis Holloway, MD

Cutting Edge Research Group, INC
Oklahoma City, OK United States
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Randall Jenkins, MD

Oregon Health & Science University
Portland, OR United States
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Melissa Henshaw, MD

Medical University of South Carolina (MUSC)
Charleston, SC United States
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James Carter, MD

Midsouth Center for Clinical Research
Memphis, TN United States
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Vijay Kusnoor, MD

Southeast Texas Clinical Research Center
Beaumont, TX United States
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Ricardo Pignatelli

Texas Children's Heart Center
Houston, TX United States
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Michael Braun, MD

Texas Children's Hospital -Research Resource Office
Houston, TX United States
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Samantha Bostrom, MD

Ericksen Research & Development, LLC
Clinton, UT United States
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Jorge Roberto Ferraris, MD

Hospital Italiano
Ciudad Autonoma, Argentina
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Beatriz Graciela Grunfeld, MD

Hospital de Ni os
Ciudad Autonoma, Argentina
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Augusto Gutierrez, MD

Hospital Universitario Austral
Pilar, Argentina
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Susana Miceli, MD

Centro Infantil del Ri on
San Miguel de Tucuman, Argentina
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Jose Hugo Paladini, MD

Clinica de Nefrologia, Urologia y Enf. Cardiovasculares S A
Santa Fe, Argentina
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Antonio Cesar Paulillo de Cillo, ...

CAEP - Centro Avan ado de Estudos e Pesquisas Ltda.
Campinas, Brazil
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Rejane de Paula Bernardes, MD

Cl nica Nefrokids Ltda
Curitiba, Brazil
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Ana Maria Teixeira Verçoza, MD

Hospital S o Lucas da PUCRS
Porto Alegre, Brazil
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Estela Suzana Kleiman Horowitz, MD

Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Brazil
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Gyane Groppo Pereira, MD

HMTJ - Hospital e Maternidade Therezinha de Jesus
São Mateus, Brazil
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Maria Cristina de Andrad, MD

Funda o Jos Luiz Egydio Set bal
São Paulo, Brazil
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Paulo César Koch Nogueira, MD

Hospital Samaritano
São Paulo, Brazil
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Míriam Damião Gomes Seabra, MD

Eurolatino Pesquisas M dicas Ltda.
Uberlândia, Brazil
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Lyubov Chochkova-Bukova, MD

UMHAT "Sv. Georgi", EAD
Plovdiv, Bulgaria
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Anesa Georgieva, MD

MHAT-Plovdiv AD
Plovdiv, Bulgaria
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Valya Milovska, MD

SHATPPD-Ruse EOOD
Ruse, Bulgaria
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Margarita Tzonzarova, MD

MHAT - "National Heart Hospital" EAD
Sofia, Bulgaria
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Lachezar Marinov, MD

MHAT 'Sv. Marina', EAD
Varna, Bulgaria
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Juan Pablo Rozo Galindo, MD

Hospital Universitario Clinica San Rafael
Bogota, Colombia
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Angela Diaz Diaz, MD

Fundacion Oftalmologica de Santander - FOSCAL
Bucaramanga, Colombia
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Jaime Manuel Restrepo, MD

Fundacion Valle del Lili
Cali, Colombia
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Maria Claudia Prada, MD

Fundacion Hospitalaria San Vicente de Paul
Medellin, Colombia
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Lina Maria Serna Higuita, MD

Hospital Pablo Tob n Uribe
Medellin, Colombia
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Ana Katherina Serrano Gayubo, MD

Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
Medellin, Colombia
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Eva Karoly, MD

Principal SMO Kft.
Baja, Hungary
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Eva Peterfai, MD

DRC Gyogyszervizsgalo Kozpont Kft
Balatonfured, Hungary
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Laszlo Kornyei, MD

Svabhegy Plusz Gyermekegeszsegugyi Kozpont
Budapest, Hungary
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Laszlo Szabo, MD

Heim Pal Gyermekkorhaz
Budapest, Hungary
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Istvan Laki, MD

Szent Lukacs Korhaz Dombovar
Dombovar, Hungary
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Peter Sipos, MD

Bekes Megyei Pandy Kalman Korhaz
Gyula, Hungary
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Laszlo Barkai, MD

Prehospital Med Kft.
Miskolc, Hungary
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Denes Molnar, MD

Pecsi Tudomanyegyetem
Pecs, Hungary
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Csaba Bereczki, MD

Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Kozp.
Szeged, Hungary
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Mario Giordana, MD

Ospedale Pediatrico Giovanni XXIII
Bari, Italy
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Patrizia Salice, MD

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano, Italy
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Silvio Maringhini, MD

A.R.N.A.S. Ospedale Civico e Benfratelli, G. Cristina e M.Ascoli
Palermo, Italy
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Sara Ordorica Sandoval, MD

Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
Culiacan, Mexico
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Karen Dublan Garcia, MD

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico
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Cesar Alberto Lucio Ramirez, MD

Accelerium S. de R.L. de C.V.
Monterrey, Mexico
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Jaime Bonilla Delgado, MD

Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, Mexico
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Ariosto Lugo Rodriguez, MD

Centro Integral Medico SJR S.C.
Queretaro, Mexico
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Anna Wasilewska, MD

SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
Bialystok, Poland
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Katarzyna Wilkosz, MD

Uniwersytecki Szpital Dzieci cy w Krakowie
Krakow, Poland
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Marcin Tkaczyk, MD

NZOZ TRI-medica
Lodz, Poland
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Roman Stankiewicz, MD

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Poland
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Malgorzata Ras, MD

Praktyka Lekarzy Rodzinnych R.Jadach, M.Domanski NZOZ
Wroclaw, Poland
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Luthando Adams, MD

LCS Clinical Research Unit
Johannesburg, South Africa
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Steve Caras, MD

Soweto Clinical Trial Centre
Soweto, South Africa
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Frank Bocking, MD

Netcare St. Anne's Hospital
Pietermaritzburg, South Africa
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Brian Rayner, MD

Groote Schuur Hospital E13 Renal Unit
Cape Town, South Africa
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Louis van Zyl, MD

Clinical Projects Research SA (PTY) LTD
Worcester, South Africa
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Ali Anarat, MD

Cukurova University Medical Faculty
Adana, Turkey
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Oguz Soylemezoglu, MD

Gazi University Medical Faculty
Ankara, Turkey
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Nese Ozkayin, MD

Trakya University Medical Faculty
Edirne, Turkey
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Ahmet Nayir, MD

Istanbul University Istanbul Medical Faculty
Istanbul, Turkey
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Salih Kavukcu, MD

Dokuz Eylul University Medicine Faculty
Izmir, Turkey
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Ruhan Dusunsel, MD

Erciyes University Medical Faculty
Kayseri, Turkey
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Ipek Akil, MD

Celal Bayar University Medical Faculty
Manisa, Turkey
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