Trial Information

Summary: CAPS (CArdene® IV Pediatric Study) A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study Of Cardene I.V. In Pediatric Subjects With Hypertension

Purpose
This Cardene I.V. study is being conducted worldwide to evaluate the efficacy, pharmacokinetics, safety, and tolerability in hypertensive pediatric patients.

Background
Cardene I.V. is a calcium channel blocker approved in the US for short-term treatment of hypertension in adults when oral therapy is not feasible or desirable and is being investigated for use in the pediatric population.

Study Design
The target population for this study is children between the age of 2 and 16 with moderate to severe hypertension.

Key eligibility criteria include:

• Evidence of stage 1 or 2 systolic hypertension at screening
• Informed consent signed by authorized representative and assent from subject as appropriate

Eligible patients will receive Cardene I.V. or placebo for 30 minutes as an intravenous infusion, with the option to extend treatment for an additional 72 hours maximum. Patients will participate in a follow up evaluation 30-35 days after the infusion.

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Trial listings updated: June 1, 2008 at 6:34:02 AM