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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014