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

PHASE3CompletedINTERVENTIONAL
Enrollment

377

Participants

Timeline

Start Date

March 30, 2015

Primary Completion Date

November 11, 2019

Study Completion Date

November 11, 2019

Conditions
Hypertension
Interventions
DRUG

Azilsartan Medoxomil Low-dose

Azilsartan medoxomil low-dose (AZM-L) 10 mg

DRUG

Losartan

DRUG

Placebo for Azilsartan Medoxomil

DRUG

Placebo for Losartan

DRUG

Azilsartan Medoxomil Medium-dose (20 mg)

Azilsartan medoxomil medium-dose (AZM-M) 20 mg

DRUG

Azilsartan Medoxomil High-dose (40 mg)

Azilsartan medoxomil high-dose (AZM-L) 40 mg

Trial Locations (69)

1037

Svabhegy Plusz Gyermekegeszsegugyi Kozpont, Budapest

1181

Hospital Italiano, Ciudad Autonoma

1818

Soweto Clinical Trial Centre, Soweto

2021

LCS Clinical Research Unit, Johannesburg

3201

Netcare St. Anne's Hospital, Pietermaritzburg

3526

Prehospital Med Kft., Miskolc

6400

Accelerium S. de R.L. de C.V., Monterrey

6500

Principal SMO Kft., Baja

6720

Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Kozp., Szeged

6850

Clinical Projects Research SA (PTY) LTD, Worcester

7002

SHATPPD-Ruse EOOD, Rousse

7200

Szent Lukacs Korhaz Dombovar, Dombóvár

7925

Groote Schuur Hospital E13 Renal Unit, Cape Town

10029

Mount Sinai PRIME, Lake Success

20122

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan

29425

Medical University of South Carolina (MUSC), Charleston

30078

Georgia Clinical Research, Snellville

30286

Zoe Center for Pediatrics, Thomaston

33012

Direct Helpers Research Center, Hialeah

33125

JDH Medical Group LLC, Miami

33136

University of Miami/Jackson Memorial Hospital, Miami

33144

Medical Research Center of Miami II, Inc., Miami

33162

Pioneer Clinical Research, North Miami

34000

Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango

34093

Istanbul University Istanbul Medical Faculty, Istanbul

35100

Dokuz Eylul University Medicine Faculty, Izmir

38039

Erciyes University Medical Faculty, Kayseri

38116

Memphis and Shelby County Pediatric Group, Memphis

39150

David M. Headley, MD PA, Port Gibson

40202

University of Louisville, Louisville

45040

Celal Bayar University Medical Faculty, Manisa

58260

Centro de Investigacion Clinica Chapultepec S.A. de C.V., Morelia

70125

Ospedale Pediatrico Giovanni XXIII, Bari

77030

Texas Children's Heart Center, Houston

77701

Southeast Texas Clinical Research Center, Beaumont

84015

Ericksen Research & Development, LLC, Clinton

92805

Advanced Research Center, INC, Anaheim

99352

Mid-Columbia Research, Richland

C1425EFD

Hospital de Niños, Ciudad Autonoma

S3000EPV

Clinica de Nefrologia, Urologia y Enf. Cardiovasculares S A, Santa Fe

80240-060

Clínica Nefrokids Ltda, Curitiba

90610-000

Hospital São Lucas da PUCRS, Porto Alegre

90620-001

Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre

01227-200

Fundação José Luiz Egydio Setúbal, São Paulo

01232-010

Hospital Samaritano, São Paulo

38411-186

Eurolatino Pesquisas Médicas Ltda., Uberlândia

Unknown

Fundacion Oftalmologica de Santander - FOSCAL, Bucaramanga

Fundacion Hospitalaria San Vicente de Paul, Medellín

Hospital Pablo Tobón Uribe, Medellín

"Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia IPS UNIVERSITARIA", Medellín

Fundacion Valle del Lili, Santiago de Cali

A.R.N.A.S. Ospedale Civico e Benfratelli, G. Cristina e M.Ascoli, Palermo

Hospital General de Mexico, Mexico City

CRISMO Bertha Gxowa Research Centre, Germiston

CMI Chernivtsi City Children Clinical Hospital, Chernivtsi

Regional Children CH Cardiology Department Kharkiv NMU, Kharkiv

SI National Research Center of Radiation Medicine of NAMSU, Kyiv

USPC of ES EO&T Transplantation of MHU, Kyiv

HSEI of Ukraine UMSA, Poltava

SSU Division MU Ch of pediatrics, Sumy

Vynnitsa Regional Children CH pediatric department № 1 M.I. Pyrogov NMU, Vinnytsia

CI Zaporizhzhia City Multibranch Children Hospital #5, Zaporizhzhia

CI Zaporizhzhia Regional Clinical Children Hospital of ZRC, Zaporizhzhia

15-274

SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa, Bialystok

30-663

Uniwersytecki Szpital Dziecięcy w Krakowie, Krakow

93-338

NZOZ TRI-medica, Lodz

50-072

Praktyka Lekarzy Rodzinnych R.Jadach, M.Domanski NZOZ, Wroclaw

01330

Cukurova University Medical Faculty, Adana

06500

Gazi University Medical Faculty, Ankara

Sponsors
All Listed Sponsors
lead

Arbor Pharmaceuticals, Inc.

INDUSTRY

NCT02235909 - An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension | Biotech Hunter | Biotech Hunter