Phase 2 N=34 Randomized Treatment

Safety and Efficacy of L-NAME and Midodrine to Increase MAP

Orthostatic Hypotension · Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT00835224 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcome: Primary: Blood Pressure — 120; 112; 117; 109 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: L-NAME (Drug); Midodrine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Pressure	120; 112; 117; 109; 96; 109	—

Summary

After a spinal cord injury the brain is no longer completely in control of the body below the level of injury. This affects many organs and systems in the body, we are interested in understanding how a spinal cord injury affects blood pressure and blood flow to the brain. We are going to study blood pressure while the person is seated in a wheelchair before and after we give the subject medications which should increase blood pressure in a laboratory setting and over the course of a normal day in persons with spinal cord injury.

Eligibility Criteria

Inclusion Criteria

Spinal Cord Injured Subjects:

chronic spinal cord injury (1 year post injury) with a seated MAP of 65mmHg (almost all individuals with tetraplegia demonstrate this)
Male or female with an age of 18 - 65 years

Control Subjects:

Male or female with an age of 18 - 65 years

Exclusion Criteria

Spinal Cord Injured Subjects:

acute illness
cardiovascular disease
renal disease
medications that affect the cardiovascular system

Control Subjects:

acute illness
cardiovascular disease
renal disease
medications that affect the cardiovascular system

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00835224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.