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S90652 in Paediatric Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202592
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 long-term safety and effects on blood pressure of a paediatric formulation of perindopril 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)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT00202592


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: NCT00202592     History of Changes
Other Study ID Numbers: CL2-90652-002
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