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Completed

NCT Number: NCT00435162

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

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 ).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sites in Belgium, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valsartan 0.25 mg/kg

Drug

once daily

Valsartan 1.0 mg/kg

Drug

once daily

Valsartan 4.0 mg/kg

Drug

once daily

Primary outcomes

  1. Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)

    Time frame: baseline and week 6

Secondary outcomes

  1. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)

    Time frame: baseline and week 6

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 14, 2007
Registry last updated
May 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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