S90652 in Paediatric Hypertension
Sponsor
Institut de Recherches Internationales Servier (Other)
Overall Status
Completed
CT.gov ID
NCT00202592
Collaborator
(none)
50
1
77
0.6
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
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
Study Start Date
:
Nov 1, 2003
Actual Primary Completion Date
:
Apr 1, 2010
Actual Study Completion Date
:
Apr 1, 2010
Outcome Measures
Primary Outcome Measures
- Clinical safety assessed from the patient's (parents) complaints and clinical follow-up []
Secondary Outcome Measures
- Blood pressure []
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Months
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Necker Enfants Malades | Paris | France |
Sponsors and Collaborators
- Institut de Recherches Internationales Servier
Investigators
- Study Chair: Patrick Niaudet, Pr, Hôpital Necker-Enfants Malades, Paris, France
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier:
NCT00202592
Other Study ID Numbers:
- CL2-90652-002
First Posted:
Sep 20, 2005
Last Update Posted:
Apr 12, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms: