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S90652 in Paediatric Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202553
First Posted: September 20, 2005
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Servier
  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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertensive children

Exclusion Criteria:

  • Renal failure
  • Unstable renal function
  • Hyperkaliemia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00202553     History of Changes
Other Study ID Numbers: CL2-90652-001
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: October 20, 2017
Last Verified: June 2011

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents