Safety 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 hypertensive children having received S 90652 - an open, non-comparative, 24-month (minimal duration), multicentre study.

Conditions: Arterial Hypertension
MedDRA version: 14.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2005-000474-42-IT

Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Children older than 2 years and 3 months Having reached the termination visit of the CL2-90652-001 after 3 months of treatment maintenance on S 90652 In whom th S 90652 treatment administered during the CL2-90652-001 study is considered by the investigator as well tolerated and fairly active on BP level
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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

Poorly controlled hypertension defined as a SBP or a DBP >o= 97.5th percentile; Girls with signs of pubescence; Estimated GFR < 25 mL/min/1.73m2 calculed from the modified Schwarts formula; Serum potassium level > 5,5 mmol/l on a recent laboratory exam

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - to extend the duration of treatment with S 90652 in children who will have completed the CL2-90652-001 study - to assess the long term safety profile of S 90652 in hypertensive children - to assess the long term effect of S 90652 on blood pressure level in hypertensive children;Secondary Objective: None;Primary end point(s): adverse events, estimated GFR, biochemical and haemotological parameters, weight and height progression, systolic and diastolic Blood Pressure

Secondary Outcome Measures