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


Tracking Information

Start Date  ICMJEMarch 2007
Estimated Primary Completion DateFebruary 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 16, 2008)		Change in mean sitting systolic blood pressure (MSSBP) [ Time Frame: baseline to week 6 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: February 13, 2007)		Change from baseline is MSSBP at Week 6
Change HistoryComplete list of historical versions of study NCT00435162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 16, 2008)
  • safety and tolerability of valsartan measured by frequency of adverse events, laboratory values, pulse, standing blood pressure, body weight [ Time Frame: at every visit ] [ Designated as safety issue: Yes ]
  • Change in mean sitting systolic blood pressure (MSSBP) at end of placebo-controlled withdrawal period [ Time Frame: from week 6 to week 8 ] [ Designated as safety issue: No ]
  • Change in mean sitting diastolic blood pressure (MSDBP) [ Time Frame: basline to week 6 ] [ Designated as safety issue: No ]
  • Change in mean sitting diastolic blood pressure (MSDBP) at end of placebo-controlled withdrawal period [ Time Frame: from week 6 to week 8 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: February 13, 2007)
  • safety and tolerability measured by frequency of adverse events, laboratory values, pulse, standing blood pressure, body weight
  • Change from Week 6 in MSSBP at Week 8 (end of placebo-controlled withdrawal period)
  • Change from baseline in MSDBP at Week 6
  • Change from Week 6 in MSDBP at Week 8 (end of placebo-controlled withdrawal period)

Descriptive Information

Brief Title  ICMJEDose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Official Title  ICMJEA 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.
Brief Summary

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 ).

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEHypertension
Intervention  ICMJEDrug: Valsartan
Study Arms / Comparison Groups
  • Valsartan 0.25 mg/kg: Experimental
    Intervention: Drug: Valsartan
  • Valsartan 1.0 mg/kg: Experimental
    Intervention: Drug: Valsartan
  • Valsartan 4.0 mg/kg: Experimental
    Intervention: Drug: Valsartan

Recruitment Information

Estimated Enrollment  ICMJE75
Estimated Completion DateFebruary 2009
Estimated Primary Completion DateFebruary 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≥ 8 kg or ≤ 40 kg at randomization
  • Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile, 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
  • Creatinine clearance < 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

GenderBoth
Ages6 Months to 5 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharmaceuticals862-778-8300
Location Countries  ICMJEUnited States,   Belgium,   Brazil,   Czech Republic,   France,   Germany,   Hungary,   India,   Italy,   Lithuania,   Poland,   Russian Federation,   Slovakia,   South Africa,   Sweden,   Switzerland,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00435162
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECVAL489K2303
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsSponsor GmbH
Information Provided ByNovartis