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S90652 in Paediatric Hypertension

This study has been completed.
Sponsor:
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT00202592
First received: September 12, 2005
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  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: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   30 Months to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
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 May 19, 2013