drugset / Trial / NCT00528827
A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-12
- Completion
- 2008-12
Outcome
Outcome not reported
Stopped (Enrollment): “Due to the sale of Cardene IV, the sponsor has stopped enrollment and withdrawn the study. No safety issues were identified.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicardipine | Small molecule | 0.5 ug/kg | Intravenous |
| Subject | Nicardipine | Small molecule | 2.5 ug/kg | Intravenous |
| Subject | Nicardipine | Small molecule | 5 ug/kg | Intravenous |