A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457626

CVAL489K2303E1

2006-005473-21 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.

Enrollment: 66 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Participants who qualified and entered the core study.
• Participants who participated in the core study, completed Period 1 and were re-randomized in Period 2 and continued for at least 3 days in Period 2.

Exclusion criteria

• Participants who did not complete Period 1 of the core study.
• Participants who were re-randomized in Period 2 of core study but did not continue for => 3 days in Period 2 of the core study.
• Participants who experienced any adverse events considered serious or drug related in the core study.
• Participants excluded from the core study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

66 participants in 1 patient group

Valsartan Open Label

Experimental group

Description:

Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg, escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.

Treatment:

Drug: Valsartan