Arterial hypertension MedDRA version: 5.1 Level: PT Classification code 10020782
Conditions
Interventions
Product Code: S 90652
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: perindopril
CAS Number: 82834-16-0
Current Sponsor code: S 09490-6
Other descriptive name: perindopril arginine sa
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to assess the acceptability (acceptance) of S 90652 - to assess the safety of S 90652;Secondary Objective: - to assess the pharmacokinetic parameters of perindopril and perindoprilat after repeated administrations of S 90652 - to assess the BP effects of S 90652 - to define the ranges of weight-adjusted doses likely to induce and maintain BP control - 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 - Safety : rate of adverse events, results of laboratory exams and results of electrocardiograms | — |
Countries
Belgium, Italy
Outcome results
None listed