Clinical Trial: Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 6 Week, Randomized, Multicenter, Double-blind, Double-dummy Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 1-5 Years Old With Hypertension, With or Without

Brief Summary: To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Change from baseline (Week 0) in mean systolic blood pressure (MSBP) at Week 6 endpoint [ Time Frame: Baseline, week 6 ]

Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) for that visit.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in mean diastolic blood pressure (MDBP) at Week 6 and end of study (26 weeks) [ Time Frame: 6 weeks, 26 weeks ]
    Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) for that visit.
  • Percentage of patients achieving MSBP < 90th percentile for age, gender and height at Week 6 endpoint and end of study (26 weeks) [ Time Frame: 6 weeks, 26 weeks ]
    Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) for that visit.
  • Number of patients with Urine Albumin Creatinine Ratio (UACR) response at Week 6 endpoint and end of study (26 weeks) [ Time Frame: 6 weeks, 26 weeks ]
    UACR response is defined as percentage change from baseline in UACR≤ 25%. UACR [mg/mmol] = urine albumin [mg/L] / urine creatinine [mmol/L]
  • Number of patients with adverse events, serious adverse events and death [ Time Frame: 26 weeks ]
    Patients safety will be based on frequency of adverse events.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: June 6, 2012
Date Started: November 8, 2012
Date Completion:
Last Updated: March 15, 2017
Last Verified: March 2017