NCT00202592

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

6.4 years

First QC Date

September 12, 2005

Last Update Submit

April 10, 2018

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Blood pressure

Interventions

PerindoprilDRUG

Eligibility Criteria

Age30 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hypertensive children, who have been treated for four months at least with S90652, with safety and efficacy

You may not qualify if:

  • Poorly controlled hypertension
  • Girls with signs of pubescence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, France

Location

MeSH Terms

Conditions

Hypertension

Interventions

Perindopril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Patrick Niaudet, Pr

    Hôpital Necker-Enfants Malades, Paris, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

November 1, 2003

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies in patients: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
More information

Locations

FR(1)