S90652 in Paediatric Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 12, 2005

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Acceptability, efficacy, pharmacokinetics

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

S90652 in Paediatric Hypertension

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, 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

Exclusion Criteria:

Renal failure
Unstable renal function
Hyperkaliemia

Gender

Both

Ages

2 Years to 16 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

NCT00202553

Responsible Party

Study ID Numbers ^ICMJE

CL2-90652-001

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