An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Hypertension
Interventions
DRUG

Aliskiren

"Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg~Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg~High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg"

DRUG

Enalapril

"Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg~Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg~High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg"

Trial Locations (36)

1083

Novartis Investigative Site, Budapest

1131

Novartis Investigative Site, Budapest

3529

Novartis Investigative Site, Miskolc

4032

Novartis Investigative Site, Debrecen

4400

Novartis Investigative Site, Nyíregyháza

6725

Novartis Investigative Site, Szeged

10016

Novartis Investigative Site, New York

25304

Novartis Investigative Site, Charleston

29425

Novartis Investigative Site, Charleston

30721

Novartis Investigative Site, Dalton

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

97225

Novartis Investigative Site, Portland

35294-0006

Novartis Investigative Site, Birmingham

07227

Novartis Investigative Site, Portland

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