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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan

• Registration Number: NCT00457626
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Study Start: 2007-04-09
• Primary Completion: 2009-05-25
• Study Completion: 2009-05-25
• Results First Submitted: 2021-04-28
• Results First Submitted QC: 2021-04-28
• Results First Posted: 2021-05-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valsartan Open Label	Valsartan	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline to Week 26	Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline to Week 26	Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three SDBP measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Week 8 to Week 26 of Extension Phase	An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Izmir, Turkey