NCT00528827

A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Facet Biotech · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension.

Detailed description

Children with acute hypertensive episodes are frequently treated with the same marketed drugs as adults. Few drugs are specifically indicated for use in children with severe hypertension. Cardene I.V. has been widely used in children with severe hypertension without specific dosing recommendations for children in the labeling. This study is designed to examine the pharmacokinetics, pharmacodynamics, safety, and efficacy of using Cardene I.V. to reduce blood pressure (BP) in children with hypertension and will provide important information to guide use in pediatric patients.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Cardene® I.V.	* 5 mcg/kg/min Cardene I.V. * 2.5 mcg/kg/min Cardene I.V. * 0.5 mcg/kg/min Cardene I.V.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-09-12
• Last updated: 2012-03-16

Locations

2 sites across 1 country: United States