EUCTR2005-000077-22-BE进行中（未招募）1 期
Acceptability, safety, pharmacokinetics and effects on blood pressure of a daily dose of 0.025 to 0.135 milligram per kilogram of S 90652, a paediatric formulation of perindopril, in 2-16 years old hypertensive children - an open, non-comparative, 3-month multicentre study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •- hypertensive children
- •- from 2 to 16 years old inclusive for boys and from 2 to 11 years old inclusive for girls
- •- estimated glomerular filtration rate = 30 millilitres / minute / 1.73 square meter
- •- no contraindication to treatment with an angiotensin converting enzyme inhibitor
- •- patients not treated for hypertension (subgroup A), patients treated with hypertension controlled (subgroup B) and patients treated with hypertension not controlled (subgroup C)
- •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
- •- Children with threatening hypertension defined as a SBP or a DBP equal to or above the 97.5th percentile + 30 mmHg. Children under 95 centimetres tall will be considered as if they were 95 cm tall.
- •- Contraindication to ACE-I: bilateral renal artery stenosis or unilateral renal artery stenosis in patients with a single functional kidney, history of angio-oedema, ongoing treatment to desensitise allergic children, severe bone marrow deficiency
- •- Dialysis treatment
- •- Children waiting for a kidney transplant procedure
- •- Severe nephrotic syndrome not in remission
- •- estimated GFR < 30 mL/min/1.73m² calculated from the modified Schwartz formula
- •- serum potassium level > 5.0 mmoles/L on a recent (within 2 days) laboratory exam or on a recent and re-checked laboratory exam
- •- unstable renal function defined as a pre-inclusion estimated GFR lower than 80% of the estimated GFR of the selection visit
- •- late discovery of any condition not in compliance with a selection criterion
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