S90652 in Paediatric Hypertension

This study has been completed.
Sponsor:
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT00202553
First received: September 12, 2005
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

The aim of the study is to assess the acceptability, safety and pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril given in hypertensive children


Condition Intervention Phase
Hypertension
Drug: Perindopril
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptability, Safety, Pharmacokinetics and Effects on Blood Pressure of a Daily Dose of 0.025 to 0.135 Milligram Per Kilogram of S90652, a Paediatric Formulation of Perindopril, in 2-16 Years Old Hypertensive Children - 3 Month Study

Resource links provided by NLM:


Further study details as provided by Servier:

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

Secondary Outcome Measures:
  • Acceptability, efficacy, pharmacokinetics

Estimated Enrollment: 50
Study Start Date: July 2003
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertensive children

Exclusion Criteria:

  • Renal failure
  • Unstable renal function
  • Hyperkaliemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202553

Locations
France
Hôpital Necker Enfants Malades
Paris, France
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Investigators
Study Chair: Patrick Niaudet, Pr Hôpital Necker Enfants Malades, Paris, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00202553     History of Changes
Other Study ID Numbers: CL2-90652-001
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014