Conditions: Hypertension
Keywords: children pediatrics high blood pressure hypertension valsartan enalapril
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 250
Healthy volunteers: no

Brief summary:
The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Valsartan intervention 2: Enalapril intervention 3: placebo matched to enalapril intervention 4: placebo matched to valsartan
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food. intervention 4: placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Protocol document: