NCT00244634已完成3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 238
- 试验地点
- 43
- 主要终点
- Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages 6 to < 17 years-of-age after parent or guardian's signing of informed consent.
- •Subjects with hypertension that is either:
- •Diagnosed and untreated with a mean sitting systolic and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation based on height-adjusted charts for age and gender; or
- •Previously diagnosed and currently treated with mean sitting systolic blood pressure and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation (off treatment) based on height-adjusted charts for age and gender.
- •Females of childbearing potential (post-menarche) must have a negative urine pregnancy test prior to randomization and adhere to a pregnancy prevention method (abstinence, barrier method plus spermicidal foam, oral, or implanted contraceptive).
- •A signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).
排除标准
- •Any situation, clinical condition or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study or would pose a significant risk to the subject or interfere with the assessment of safety and efficacy endpoints.
- •Hypertension secondary to coarctation of the aorta, pheochromocytoma, hyperthyroidism, Cushing's syndrome, or medications (eg: corticosteroids).
- •Known history of bilateral renal artery stenosis, unilateral renal artery stenosis or a renal transplant.
- •Glomerular filtration rate < 50 mL/min based on an estimated value using the Schwartz Formula.
- •Nephrotic syndrome not in remission.
- •Insulin dependent diabetes mellitus.
- •Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling.
- •Clinically significant valvular heart disease.
- •Clinical diagnosis of heart failure.
- •Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms).
- •Second or third degree AV block.
- •Pregnant or breast-feeding an infant.
- •Impaired liver function defined as either acute liver disease or chronic liver disease with persistent liver enzyme values greater than 1½ times the upper limit of the reference range for AST or ALT.
- •Known hypersensitivity to ARBs.
- •Unable to be off antihypertensive medication (diuretics, beta blockers, ACE Inhibitors, etc) for 6-weeks.
- •Inability to discontinue medications which may contribute to elevated blood pressure e.g. systemic corticosteroids.
- •Currently using, or used within 14 days prior to receiving double-blind medication, any concomitant medications which in the opinion of the investigator could negatively affect the subject.
- •Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug tablets.
- •Received an investigational agent within 30 days prior to receiving study medication.
- •Alcohol or drug abuse.
结局指标
主要结局
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
次要结局
- 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.
研究者
研究点 (43)
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