EUCTR2014-000674-18-HU进行中（未招募）1 期
A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •* The subject has hypertension (primary or secondary) defined as clinic seDBP =95th percentile (by age, gender, and height) or =90th percentile (by age, gender, height) if chronic renal disease, diabetes, heart failure or hypertensive target organ damage is present.
- •a) If currently treated: The subject has a documented historical diagnosis of hypertension AND a post-washout clinic seDBP meeting the above criteria on Day -1 (or Day 1 for subjects not participating in ABPM).
- •b) If currently untreated: The subject has elevated seDBP meeting the above criteria on 3 separate occasions before Randomization, including on Day -1 (or Day 1 for subjects not participating in ABPM).
- •* The subject is male or female and aged 6 to <18 years at Baseline and weighs at least 25 kg.
- •* The subject agrees to continue their previously implemented nonpharmacological life style modifications if begun prior to Screening. Note: For subjects participating in a weight loss program, the weight maintenance phase must have begun at least 30 days prior to Screening/Visit 1.
- •* Subjects may be renal transplant patients if time post-transplant has been greater than 6 months prior to Screening, with stable graft function (and eGFR =30 mL/min/1.73 m2) for at least 6 months, stable use of immunosuppressive therapy for at least 30 days prior to Screening, and documented evidence that there is no transplant renal artery stenosis.
- •* The subject is untreated, or willing, and in the opinion of their treating physician, can safely be withdrawn from previous antihypertensive medications for a maximum of 4 weeks (if a washout extension is required) prior to randomization.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 260
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •*The subject has a clinic seSBP greater than 15 mm Hg and/or seDBP greater than 10 mm Hg above the 99th percentile for age, gender, and height as confirmed by the average (arithmetic mean) of 3 serial clinic seated BP measurements at Screening/Visit 1.
- •* The subject has a diagnosis of malignant or accelerated hypertension.
- •* The subject is currently treated with more than 2 antihypertensive agents.
- •* The subject or parent/legal guardian is not willing for the subject’s previous antihypertensive medications to be stopped.
- •* The subject has participated in the intensive, active weight-loss phase of a weight-loss program within 30 days prior to Screening/Visit 1.
- •* The subject has any of the following: severe renal impairment (eGFR <30 mL/min/1.73 m2 by the Schwartz formula); is currently undergoing dialysis treatment; renovascular disease affecting both kidneys or a solitary kidney; severe nephrotic syndrome not in remission; or serum albumin <2.5 g/dL.
- •* The subject has a history or clinical manifestations of severe cardiovascular, hepato-biliary, gastrointestinal, endocrine-metabolic (eg, hyperthyroidism, Cushing’s syndrome), hematologic, immunologic, genito-urinary, or psychiatric disease, cancer, and/or any conditions that would interfere with the health status of the subject through study participation, or would jeopardize study integrity in the opinion of the investigator.
- •* The subject is suffering from uncorrected coarctation of the aorta, or hemodynamically significant left ventricular outflow tract obstruction due to eg, aortic valvular disease, or is likely to undergo a procedure known to affect blood pressure (eg, repair of arterial anomalies) during the course of the study.
- •* The subject is poorly controlled diabetic defined as having a glycosylated hemoglobin value >8.5% at Screening/Visit 1.
- •* The subject has hyperkalemia as defined by the central laboratory’s normal reference range or any pertinent electrolyte disorders at Screening/Visit 1.
研究者
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