S90652 in Paediatric Hypertension

This study is currently recruiting participants.

Verified by Servier, September 2005

First Received: September 12, 2005 No Changes Posted

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

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

Contacts

Contact: Patrick Niaudet, Pr

+ 33 1 44 49 44 44

Locations

France
Hôpital Necker Enfants Malades	Recruiting
Paris, France
Contact: Patrick Niaudet, Pr + 33 1 44 49 44 44

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

Study ID Numbers:	CL2-90652-001
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00202553 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Perindopril
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010