Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
HypertensionChronic Kidney Disease
Interventions
DRUG

Valsartan

week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily

DRUG

amlodipine

added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose

DRUG

Hydrochlorothiazide

added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose

Trial Locations (28)

1000

Novartis Investigative Site, Manila

1100

Novartis Investigative Site, Quezon City

1101

Novartis Investigative Site, Quezon City

18107

Novartis Investigative Site, Rostock

20395

Novartis Investigative Site, Bucharest

44791

Novartis Investigative Site, Bochum

66421

Novartis Investigative Site, Homburg

79106

Novartis Investigative Site, Freiburg im Breisgau

119074

Novartis Investigative Site, Singapore

119991

Novartis Investigative Site, Moscow

125315

Novartis Investigative Site, Moscow

127412

Novartis Investigative Site, Moscow

229899

Novartis Investigative Site, Singapore

300011

Novartis Investigative Site, Timișoara

394036

Novartis Investigative Site, Voronezh

420012

Novartis Investigative Site, Kazan'

540104

Novartis Investigative Site, Tg. Mures

700309

Novartis Investigative Site, Iași

0001

Novartis Investigative Site, Bucaramanga

Unknown

Novartis Investigative Site, Barranquilla

Novartis Investigative Site, Santiago de Cali

Novartis Investigative Site, Cluj-Napoca

00029

Novartis Investigative Site, Helsinki

03048

Novartis Investigative Site, Cottbus

01010

Novartis Investigative Site, Guatemala City

04-154

Novartis Investigative Site, Warsaw

041451

Novartis Investigative Site, Bucharest

03080

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY