S90652 in Paediatric Hypertension
Sponsor
Institut de Recherches Internationales Servier (Other)
Overall Status
Completed
CT.gov ID
NCT00202553
Collaborator
(none)
50
1
41
1.2
Study Details
Study Description
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
| 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)
Primary Purpose:
Treatment
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
Study Start Date
:
Jul 1, 2003
Actual Study Completion Date
:
Dec 1, 2006
Outcome Measures
Primary Outcome Measures
- Safety assessed from the patient's (parents) complaints and the clinical follow-up []
Secondary Outcome Measures
- Acceptability, efficacy, pharmacokinetics []
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Hypertensive children
Exclusion Criteria:
-
Renal failure
-
Unstable renal function
-
Hyperkaliemia
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:
,
,
ClinicalTrials.gov Identifier:
NCT00202553
Other Study ID Numbers:
- CL2-90652-001
First Posted:
Sep 20, 2005
Last Update Posted:
Apr 11, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms: