drugset / Trial / NCT03602014

Dose Response to the Norepinephrine Precursor Droxidopa in Hypotensive Individuals With Spinal Cord Injury

NCT03602014

RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this study is to determine the efficacy of the drug Droxidopa (Northera) in increasing blood pressure in subject with hypotension, low blood pressure, which is classified as blood pressure less than 110/70 in males and 100/70 in females. The first aim is to determine the proportion of subject with Spinal Cord Injury (SCI) who have a normotensive response to Droxidopa. The second is to determine the proportion of subject with SCI who express a hypertensive response to Droxidopa. A Normal blood pressure ranges from 111-139 in males and 101-139 in females and a hypertensive blood pressure is anything higher than 140 in males and females. The study would take place in James J. Peters VA Medical Center (JJPVAMC) and The Icahn School of Medicine at Mount Sinai (ISMMS) in Manhattan, New York.

Timeline

Start
2018-06-01
Primary completion
2021-12-31
Completion
2021-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Droxidopa Small molecule 200 mg Oral
Subject Droxidopa Small molecule 300 mg Oral
Subject Droxidopa Small molecule 400 mg Oral
Subject Droxidopa Small molecule 500 mg Oral
Subject Droxidopa Small molecule 600 mg Oral
Subject Droxidopa Small molecule 700 mg Oral
Subject Droxidopa Small molecule 800 mg Oral