S90652 in Paediatric Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 12, 2005

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinical safety assessed from the patient's (parents) complaints and clinical follow-up

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Blood pressure

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

S90652 in Paediatric Hypertension

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Perindopril

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Months to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Patrick Niaudet, Pr

+ 33 1 44 49 44 44

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00202592

Responsible Party

Study ID Numbers ^ICMJE

CL2-90652-002

Study Sponsor ^ICMJE

Institut De Recherche International Servier

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Patrick Niaudet, Pr

Hôpital Necker Enfants Malades, Paris, France

Information Provided By

Servier

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP