Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age
The objectives of this study are to describe candesartan cilexetil antihypertensive effects in terms of achieved blood pressure and hypertension control rates and the relationship between subject characteristics and antihypertensive efficacy, and between antihypertensive therapy (candesartan cilexetil dose and add-on treatments) and efficacy over a 1 year treatment period in hypertensive children ages 6 to < 17 years; to describe growth in terms of height and weight in the study population; to describe change in neurocognition as assessed by the Full Scaled IQ score in a subset of study subjects; to determine the pharmacokinetics of candesartan in hypertensive paediatric subjects ages 6 to < 17 years; and to describe safety including adverse events and adverse events necessitating study drug discontinuation including dose level and dose duration relationships and growth over a 1 year period in hypertensive children age 6 to < 17 years.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Multinational, Open-Label Study of the Efficacy, Safety, and Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age|
- - Achieved sitting, trough, systolic blood pressure summarized over time and at Week 52 & the mean of the last two measures.
- - The measure of effect is the mean value and the corresponding descriptive statistics.
- - Additional measures include mean diastolic blood pressure, and the proportion of subjects meeting 'controlled' criteria.
- - Subject and baseline characteristics, antecedent treatment (eg, in 261A, an double-blind placebo-controlled efficacy study that is described elsewhere)
- - The relationship to efficacy measures
- - The relationship of antihypertensive treatment (candesartan cilexetil dose; add on therapy) and achieved blood pressure.
|Study Start Date:||September 2003|
|Study Completion Date:||November 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244595
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|Study Director:||AstraZeneca Atacand Medical Science Director, MD||AstraZeneca|