EUCTR2006-005260-88-SK进行中（未招募）1 期
A multicenter, randomized, double-blind, parallel-group, evaluation of 12 weeks of valsartan compared to enalapril on sitting systolic blood pressure in children 6 to 17 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
- 300
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
- •Male or female, ages 6-17 at randomization, with a documented history of
- •hypertension
- •Must be able to swallow a pill
- •Must be = 18 kg or =160 kg at randomization (Visit 2)
- •Must be able to safely wash out antihypertensive therapy
- •MSSBP (mean of 3 measurements) must be = 95th percentile, for age, gender and
- •height, at Visit 2 (randomization), by office blood pressure measurement
- •Patients who are eligible and able to participate in the study and whose parent
- •(s)/guardian(s) consent in writing (written informed consent) to their doing so
- •after the purpose and nature of the investigation has been clearly explained to
- •them. (An assent will be required for some patients depending upon their age and
- •local requirements regarding assents)
- •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
- •For full list, refer to protocol
- •Patients with any of the following physiological states or concomitant medical conditions at the screening visit will be excluded from participation in the study
- •Any clinically significant abnormalities or clinically noteworthy abnormal laboratory
- •values (other than those relating to renal function), including but not limited to
- •the following:
- •AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range. Patients
- •known to have active or chronic hepatitis will be excluded.
- •Total bilirubin >2 times the upper limit of the reference range
- •GFR <30 mL/min/1.73m² (calculated using Modified Schwartz
- •formula to estimate glomerular filtration rate [GFR]), based on the serum
- •creatinine concentration obtained at the screening visit
- •WBC count <3000/mm³
- •Platelet count <100,000/mm³
- •Serum potassium >5.3 mEq/L
- •Unilateral, bilateral and graft renal artery stenosis
- •Current diagnosis of heart failure (NYHA Class II-IV).
- •MSSBP = 25% above the 95th percentile
- •Patient that demonstrate clinically significant ECG abnormalities such as concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. In addition patients with second or third degree heart block without a pacemaker. Patients with ECG abnormalities associated with left ventricular hypertrophy are permitted to enroll.
- •Patients that have coarctation of the aorta with gradient of =30 mm Hg
- •Previous solid organ transplantation except renal, liver or heart transplantation.
- •Renal, liver or heart transplant must have occurred at least 6 months prior to
- •enrollment. Patient must be on stable doses of immunosuppressive therapy for 3
- •months and deemed clinically stable by the investigator.
- •Patient that is known to have tested seropositive for the human immunodeficiency virus (HIV) and patient is noncomitantly receiving anti-retroviral therapy
研究者
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