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S90652 in Paediatric Hypertension

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ClinicalTrials.gov Identifier: NCT00202592
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Perindopril Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : November 2003
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Blood pressure


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

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

Additional Information:
Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT00202592     History of Changes
Other Study ID Numbers: CL2-90652-002
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies in patients:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: http://clinicaltrials.servier.com

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