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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
95
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
Research Site
Birmingham, Alabama, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Miami, Florida, United States
Research Site
Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)
Time frame: From randomisation to end of double-blind treatment (4 weeks)
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
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Orlando, Florida, United States
Research Site
Boise, Idaho, United States
Research Site
Detroit, Michigan, United States
Research Site
Durham, North Carolina, United States
Research Site
Cleveland, Ohio, United States
...and 28 more locations