Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
|ClinicalTrials.gov Identifier: NCT00244634|
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : December 19, 2007
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive pediatric subjects.
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 or placebo. The study includes 2 panels based on subject weight.
The primary efficacy analysis is based on the intent-to-treat population and tests for slope = 0 in a linear regression model with change in sitting systolic blood pressure as the dependent and non-zero dose pooled across weight panels as the independent variable. For subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value forward assigns the value.
Additional analyses will include data pooled from a similar dose ranging study conducted in children 1 to < 6 years of age.
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Hypertension||Drug: candsartan cilexetil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Dose-Ranging and Safety Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 6 to <17 Years of Age: A 4-Week, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||November 2005|
- Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.
- The endpoint (outcome variable) is the slope by linear regression
- To further evaluate the antihypertensive effects and the safety of candesartan cilexetil in hypertensive pediatric subjects.
- Determine the slope of the change from baseline to double-blind treatment in:
- • trough sitting diastolic blood pressure,
- • trough standing diastolic blood pressure and standing systolic blood pressure,
- • trough sitting pulse pressure.
- - Mean change from baseline in SiSBP, SiDBP, pulse pressure, and standing SBP and DBP relative to placebo for each dose group and for all dose groups pooled
- - Safety as assessed by adverse events, adverse events that necessitate study drug discontinuation, SAEs, heart rate, electrocardiographic findings, physical exam findings, and laboratory tests.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244634
Show 44 Study Locations
|Study Director:||AstraZeneca Atacand Medical Science Director, MD||AstraZeneca|