At a glance
ClinicalIndex Comparison Record- ✓Weight between 10 and 40 kg
- ✓Elevated systolic and/or diastolic blood pressure (SiSBP and/or SiDBP >95th percentile and <20 mm Hg systolic or <10 mm Hg diastolic above 95th percentile on height-adjusted charts for age and gender) at screening and randomization
- ✓At least 80% compliance with study medication during single-blind placebo screening period
- ✓Signed informed consent by a parent or legal guardian
- ✕Weight <10 kg or >40 kg
- ✕Secondary hypertension from pheochromocytoma, hyperthyroidism, or Cushing's Syndrome
- ✕Uncorrected coarctation of the aorta or bilateral renal artery stenosis in a single kidney
- ✕Estimated GFR <50 mL/min/1.73m² by Schwartz Formula
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 1-year, Open-label, Follow-up Period.
In Brief
A Phase 3 clinical trial evaluating candesartan cilexetil (Atacand) for Hypertension. Completed, enrolled 95 participants across 38 sites in 10 countries.
Detailed 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.
Study Details
Timeline
Interventions
0.05 mg/kg once daily oral liquid dose
0.20 mg/kg once daily oral liquid dose
0.40 mg/kg once daily oral liquid dose