FindTrial
Sign In

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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000474-42-IT
Enrollment
60
Registered
2007-10-15
Start date
2006-12-06
Completion date
Unknown
Last updated
2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: perindopril Product Code: S 90652 Pharmaceutical Form: Buccal tablet INN or Proposed INN: Perindopril CAS Number: 107133-36-8 Concentration unit: µg microgram(s) Concentration number: 15

Sponsors

INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Poorly controlled hypertension defined as a SBP or a DBP >o= 97.5th percentile; Girls with signs of pubescence; Estimated GFR 5,5 mmol/l on a recent laboratory exam

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026