Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Hypertension
Interventions
DRUG

Valsartan

Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.

DRUG

Enalapril

Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.

DRUG

placebo matched to enalapril

Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

DRUG

placebo matched to valsartan

placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Trial Locations (9)

07936

Sites in USA, East Hanover

Unknown

Sites in Belgium, Belgium

Sites in France, France

Sites in Germany, Germany

Sites in Hungary, Hungary

Sites in India, India

Sites in Italy, Italy

Sites in Poland, Poland

Sites in Turkey, Turkey

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY