Your session is about to expire
← Back to Search
Vasopressin Antagonist
Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
Phase 1
Waitlist Available
Led By Jesse J Corry, MD
Research Sponsored by Jesse Corry
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 168 hours post-enrollment
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
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.
Eligible Conditions
- Intracerebral Hemorrhage
- Cerebral Edema
- Stroke
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 168 hours post-enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 168 hours post-enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient Tolerance of Conivaptan
Secondary study objectives
Change in Cerebral Edema
Cost
In-hospital Mortality
+1 moreSide effects data
From 2008 Phase 4 trial • 121 Patients • NCT004355917%
Constipation
7%
Chest pain
3%
Bile duct obstruction
3%
Bacteraemia
3%
Bladder cancer
3%
Haemodialysis
3%
Pulmonary embolism
3%
Collapse of lung
3%
Renal failure
3%
Cardiac failure congestive
3%
Hyponatraemia
3%
Diarrhoea
3%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Regimen 3
Dose Regimen 1
Dose Regimen 4
Dose Regimen 2
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Conivaptan Treatment GroupExperimental Treatment1 Intervention
All seven patients in this arm will receive conivaptan as described in Interventions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Conivaptan
FDA approved
Find a Location
Who is running the clinical trial?
Jesse CorryLead Sponsor
Jesse J Corry, MDPrincipal InvestigatorAllina Health