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
  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:


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
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: 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
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 October 29, 2014