drugset / Trial / NCT03000283

Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study

NCT03000283

Phase 1 Completed 7 enrolled Jesse Corry
NaSingle-groupOpen-labelTreatment

Summary

The goal of this study is to preliminarily determine/estimate feasibility and whether frequent and early conivaptan use, at a dose currently determined to be safe (i.e., 40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This study is also an essential first step in understanding the role of conivaptan in CE management. Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage and pressure.

Timeline

Start
2017-03-22
Primary completion
2019-02-12
Completion
2019-04-15

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Conivaptan Small molecule 20 mg Intravenous