Conditions: Hypertension Chronic Kidney Disease
Keywords: Hypertension, pediatric Hypertension with or without chronic kidney disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 150
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.

Detailed description:

Arms:
arm 1: Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.

Interventions: intervention 1: Valsartan intervention 2: amlodipine intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily intervention 2: added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose intervention 3: added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose

Protocol document: