S90652 in Paediatric Hypertension

This study has been completed.

First Received on September 12, 2005. Last Updated on June 15, 2011 History of Changes

Sponsor:	Institut De Recherche International Servier
Information provided by:	Servier
ClinicalTrials.gov Identifier:	NCT00202553

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 II

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Perindopril Perindopril erbumine

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202553

Locations

France
Hôpital Necker Enfants Malades
Paris, France

Sponsors and Collaborators

Institut De Recherche International 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 - French Health Products Safety Agency

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 February 12, 2012