S90652 in Paediatric Hypertension
Information source: Servier
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Perindopril (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Institut De Recherche International Servier Official(s) and/or principal investigator(s):
Patrick Niaudet, Pr, Study Chair, Affiliation: Hôpital Necker Enfants Malades, Paris, France
Overall contact:
Patrick Niaudet, Pr, Phone: + 33 1 44 49 44 44
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
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Safety assessed from the patient's (parents) complaints and the clinical follow-up
Secondary outcome: Acceptability, efficacy, pharmacokinetics
Eligibility
Minimum age: 2 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hypertensive children
Exclusion Criteria:
- Renal failure
- Unstable renal function
- Hyperkaliemia
Locations and Contacts
Patrick Niaudet, Pr, Phone: + 33 1 44 49 44 44
Hôpital Necker Enfants Malades, Paris, France; Recruiting
Patrick Niaudet, Pr, Phone: + 33 1 44 49 44 44
Additional Information
Starting date: July 2003
Last updated: September 12, 2005
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