Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Hypertension
Interventions
DRUG

Aliskiren (6.25/12.5/25 mg)

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.

DRUG

Aliskiren (37.5/75/150 mg)

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.

DRUG

Aliskiren (150/300/600 mg)

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.

Trial Locations (48)

1083

Novartis Investigative Site, Budapest

1090

Novartis Investigative Site, Brussels

1131

Novartis Investigative Site, Budapest

2650

Novartis Investigative Site, Edegem

3000

Novartis Investigative Site, Leuven

3529

Novartis Investigative Site, Miskolc

4032

Novartis Investigative Site, Debrecen

4400

Novartis Investigative Site, Nyíregyháza

6725

Novartis Investigative Site, Szeged

9000

Novartis Investigative Site, Ghent

10016

Novartis Investigative Site, New York

15224

Novartis Investigative Site, Pittsburgh

25304

Novartis Investigative Site, Charleston

29425

Novartis Investigative Site, Charleston

30322

Novartis Investigative Site, Atlanta

30721

Novartis Investigative Site, Dalton

32504

Novartis Investigative Site, Pensacola

35039

Novartis Investigative Site, Marburg

35340

Novartis Investigative Site, Izmir

39209

Novartis Investigative Site, Jackson

39401

Novartis Investigative Site, Hattiesburg

40202

Novartis Investigative Site, Louisville

43205

Novartis Investigative Site, Columbus

43606

Novartis Investigative Site, Toledo

60068

Novartis Investigative Site, Park Ridge

72202

Novartis Investigative Site, Little Rock

79106

Novartis Investigative Site, Amarillo

83501

Novartis Investigative Site, Lewiston

84103

Novartis Investigative Site, Bratislava

85107

Novartis Investigative Site, Bratislava

90048

Novartis Investigative Site, Los Angeles

90701

Novartis Investigative Site, Myjava

91701

Novartis Investigative Site, Trnava

92123

Novartis Investigative Site, San Diego

97225

Novartis Investigative Site, Portland

97239

Novartis Investigative Site, Portland

98105

Novartis Investigative Site, Seattle

35294-0006

Novartis Investigative Site, Birmingham

07601

Novartis Investigative Site, Hackensack

01010

Novartis Investigative Site, Guatemala City

H-8200

Novartis Investigative Site, Veszprém

04-154

Novartis Investigative Site, Warsaw

00907

Novartis Investigative Site, San Juan

03601

Novartis Investigative Site, Martin

08001

Novartis Investigative Site, Prešov

06100

Novartis Investigative Site, Ankara

06490

Novartis Investigative Site, Ankara

06500

Novartis Investigative Site, Ankara

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY