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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - to assess the acceptability (acceptance) of S 90652<br>- to assess the safety of S 90652;Secondary Objective: - to assess the pharmacokinetic parameters of perindopril and perindoprilat after repeated administrations of S 90652<br>- to assess the BP effects of S 90652<br>- to define the ranges of weight-adjusted doses likely to induce and maintain BP control<br>- to assess the effect of S 90652 on plasmatic ACE activity in hypertensive children, aged from 2 to 16 years old.;Primary end point(s): - Acceptability : rate of discontinuations of treatment due to the refusal of orodispersible tablets<br>- Safety : rate of adverse events, results of laboratory exams and results of electrocardiograms

Secondary Outcome Measures

Name	Time	Method

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