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S90652 in Paediatric Hypertension

This study has been completed.
Information provided by:
Servier Identifier:
First received: September 12, 2005
Last updated: June 15, 2011
Last verified: June 2011
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

Condition Intervention Phase
Drug: Perindopril
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Servier:

Primary Outcome Measures:
  • Clinical safety assessed from the patient's (parents) complaints and clinical follow-up

Secondary Outcome Measures:
  • Blood pressure

Estimated Enrollment: 50
Study Start Date: November 2003
Study Completion Date: April 2010

Ages Eligible for Study:   30 Months to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00202592

Hôpital Necker Enfants Malades
Paris, France
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Study Chair: Patrick Niaudet, Pr Hôpital Necker-Enfants Malades, Paris, France
  More Information Identifier: NCT00202592     History of Changes
Other Study ID Numbers: CL2-90652-002 
Study First Received: September 12, 2005
Last Updated: June 15, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on October 21, 2016