At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.
In Brief
A Phase 3 clinical trial evaluating Valsartan, Enalapril, and 2 other interventions for Hypertension. Completed, enrolled 250 participants across 9 sites in 9 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.