EUCTR2009-017029-20-FR进行中（未招募）1 期
A multicenter, double-blind, randomized, 52 week extension study to evaluate the long term safety, tolerability and efficacy of aliskiren compared to enalapril in pediatric hypertensive patients 6-17 years of age
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
- 220
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
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •Informed consent form (approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)) signed by the parent(s)/legal guardian(s), after the purpose and nature of the investigation has been clearly explained to the parents and the patient, and prior to any study procedure for the extension study. An assent may be required for some patients depending upon their age and the local requirements regarding assents.
- •Male or female, ages 6-17 years old, i.e. age at Visit 2 (randomization), in study
- •CSPP100A2365, with a documented diagnosis of hypertension as defined in the NHLBI 4th Report 2004
- •msSBP (mean of 3 systolic blood pressure measurements) must be = 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
- •Must be = 20 kg and = 150 kg at Visit 2 (randomization), in study CSPP100A2365
- •Must be able to swallow minitablets (2mm in diameter) administered in soft food
- •Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious and drug-related adverse event(s).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Patients who experienced any adverse event(s) considered serious and drug-related, in study CSPP100A2365, are excluded from participation in study CSPP100A2365E1
- •Any clinically significant abnormalities or clinically noteworthy abnormal laboratory
- •values (other than those relating to renal function) at Visit 2 baseline (CSPP100A2365), including but not limited to the following :
- •AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
- •Total bilirubin > 2 times the upper limit of the reference range
- •Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz
- •formula to estimate glomerular filtration rate [GFR]), based on based on the serum
- •Creatinine concentration obtained at the screening visit
- •WBC count < 3000/mm³
- •Platelet count < 100,000/mm³
- •Serum potassium > 5.2 mEq/L
- •Renal artery stenosis
- •History of angioedema
- •Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or
- •obstructive valvular disease
- •msSBP = 25% above the 95th percentile
- •Second or third degree heart block without a pacemaker
- •Atrial fibrillation or atrial flutter at Visit 1 or 6 of CSPP100A2365, or potentially life threatening, or any symptomatic arrhythmia during the 12 months prior to Visit 1 of CSPP100A2365
- •Previous solid organ transplantation
- •Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
- •Human immunodeficiency virus (HIV) by history and/or the patient is concomitantly
- •receiving anti-retroviral therapy for the treatment of HIV
- •Any clinically significant unstable medical condition or chronic disease that would put the patient at risk of experiencing an adverse event associated with the expected pharmacodynamic effects of the study medication
- •Any surgical or medical condition or concomitant medication which might significantly
- •alter the absorption, distribution, metabolism, or excretion of study medication including, but not limited to, any of the following :
- •History of major gastrointestinal tract surgery such as gastrectomy,
- •gastroenterostomy, or bowel resection
- •For a complete list of the exclusion criteria, please refer to protocol, section 6.2
研究者
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