Clinical Trial: Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age

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

Official Title: A Dose-ranging Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less That 6 Years of Age: A 4-week, Multicenter, Randomized, Double-blind Study With a

Brief Summary: This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in, after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment will be performed and subjects may begin the 52-week, open-label treatment period of the study.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP) [ Time Frame: From randomisation to end of double-blind treatment (4 weeks) ]

Original Primary Outcome:

  • Characterize the dose response relationship of
  • candesartan cilexetil (once-daily) in hypertensive pediatric subjects (1 to <6 years of age) by evaluation of:
  • - the slope of the linear regression for the change in trough sitting systolic blood pressure (SiSBP) from baseline to the end of the double-blind phase


Current Secondary Outcome:

  • Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) [ Time Frame: From randomisation to end of double-blind treatment (4 weeks) ]
  • Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28 [ Time Frame: From randomisation to day 28 ]
  • Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28 [ Time Frame: From randomisation to day 28 ]


Original Secondary Outcome:

  • Evaluate the antihypertensive effects and the safety of candesartan cilexetil in hypertensive pediatric subjects by determining:
  • - the dose response relationship of candesartan cilexetil for the change in sitting and supine diastolic and systolic
  • blood pressure
  • - the mean change in urinary protein/creatinine and albumin/creatinine ratio
  • - Safety as assessed by adverse events, adverse events that necessitate study drug discontinuation, serious adverse events, physical exam findings, growth, and laboratory tests


Information By: AstraZeneca

Dates:
Date Received: October 25, 2005
Date Started: November 2004
Date Completion:
Last Updated: August 29, 2011
Last Verified: August 2011