S90652 in Paediatric Hypertension

Overview

The aim of the study is to assess the long-term safety and effects on blood pressure of a paediatric formulation of perindopril in hypertensive children

Full Title of Study: “Safety and Effects on Blood Pressure of Daily Dose 0.025 to 0.135 Milligram Per Kilogram of S90625 a Paediatric Formulation of Perindopril, in Hypertensive Children – 24 Months”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
• Study Primary Completion Date: April 2010

Interventions

• Drug: Perindopril

Clinical Trial Outcome Measures

Primary Measures

• Clinical safety assessed from the patient’s (parents) complaints and clinical follow-up

Secondary Measures

• Blood pressure

Participating in This Clinical Trial

Inclusion Criteria

• Hypertensive children, who have been treated for four months at least with S90652, with safety and efficacy

Exclusion Criteria

• Poorly controlled hypertension
• Girls with signs of pubescence

Gender Eligibility: All

Minimum Age: 30 Months

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Institut de Recherches Internationales Servier
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Patrick Niaudet, Pr, Study Chair, Hôpital Necker-Enfants Malades, Paris, France