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Antidote
Low for High Blood Pressure
Phase 4
Waitlist Available
Led By Deepak Malhotra, MD, PhD
Research Sponsored by National Institute on Aging (NIA)
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 screening, and after first and second infusions
Awards & highlights
Study Summary
The purpose of this study is to examine the effects of the digibind drug on hemodialysis patients with high blood pressure. Digibind is used to treat toxicity from digoxin and digoxin-like molecules which may contribute to high blood pressure.
Eligible Conditions
- High Blood Pressure
- Hemodialysis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, and 24-hour period after first infusion and after second infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, and 24-hour period after first infusion and after second infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure
Secondary outcome measures
Marinobufagenin levels
Side effects data
From 2018 Phase 4 trial • 178 Patients • NCT031360682%
hemmorhage
1%
pregnancy labor
1%
fever
1%
cramping
1%
severe nausea
1%
vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Digoxin
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: MediumExperimental Treatment1 Intervention
0.4mg/kg
Group II: LowExperimental Treatment1 Intervention
0.1mg/kg
Group III: HighExperimental Treatment1 Intervention
1.6 mg/kg
Group IV: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)Lead Sponsor
1,679 Previous Clinical Trials
28,021,632 Total Patients Enrolled
University of Toledo Health Science CampusOTHER
40 Previous Clinical Trials
16,590 Total Patients Enrolled
Deepak Malhotra, MD, PhDPrincipal InvestigatorUniversity of Toledo
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