Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

April 15, 2011 updated by: Novartis Pharmaceuticals

A Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Belgium, Belgium
        • Sites in Belgium
  • Brazil
      • Brazil, Brazil
        • Sites in Brazil
  • France
      • Paris, France
        • Sites in France
  • Hungary
      • Hungary, Hungary
        • Sites in Hungary
  • India
      • India, India
        • Sites in India
  • Italy
      • Italy, Italy
        • Sites in Italy
  • Poland
      • Poland, Poland
        • Sites in Poland
  • South Africa
      • South Africa, South Africa
        • Sites in South Africa
  • Sweden
      • Sweden, Sweden
        • sites in Sweden
  • Turkey
      • Turkey, Turkey
        • Sites in Turkey
  • United States
    • New Jersey
      • USA, New Jersey, United States
        • Sites in USA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension
  • Must be able to swallow liquid formulation
  • Must be ≥ 6 kg or ≤ 40 kg at randomization
  • Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization
  • If patients enter with uncontrolled BP they can remain on background antihypertensives with an unchanged dosing regimen
  • If patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy
  • Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language

Exclusion Criteria:

  • Patients with background ARB therapy
  • Patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)
  • AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range
  • Glomerular filtration rate < 30 mL/min/1.73m²
  • Serum potassium > upper limit of the reference range
  • MSSBP ≥ 25% above the 95th percentile
  • Patients exhibiting clinically significant ECG abnormalities
  • Patients that have coarctation of the aorta with a gradient of ≥ 30 mm Hg, or renal artery stenosis

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose
Drug: Valsartan 4.0 mg/kg
once daily
Experimental: Low Dose
Drug: Valsartan 0.25 mg/kg
once daily
Experimental: Medium Dose
Drug: Valsartan 1.0 mg/kg
once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
Time Frame: baseline and week 6
baseline and week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)
Time Frame: baseline and week 6
baseline and week 6
Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Time Frame: week 6 and week 8
week 6 and week 8
Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Time Frame: week 6 and week 8
week 6 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 13, 2007

First Submitted That Met QC Criteria

February 13, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 9, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAL489K2303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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