At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years and ambulatory
- ✓Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, pure autonomic failure, or autonomic neuropathies (neurogenic orthostatic hypotension)
- ✓Manifests at least one symptom while standing (dizziness, lightheadedness, feeling faint, or feeling like they may black out) or has history of such symptoms when untreated
- ✓Willing and able to undergo study procedures including morning office visits, assessments, protocol compliance, and wash-out period participation
- ✕Pregnant or lactating female
- ✕Pre-existing sustained supine hypertension greater than 180 systolic and 110 diastolic mmHg
- ✕Taking medications such as vasodilators, pressors, diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers, combined alpha and beta-blockers, MAOIs, herbals, or specific mixed effect medications
- ✕History of pheochromocytoma, congestive heart failure within 6 months, myocardial infarction within 6 months, symptomatic coronary artery disease, ventricular tachycardia, or uncontrolled cardiac arrhythmias
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride in Patients With Neurogenic Orthostatic Hypotension
In Brief
A Phase 4 clinical trial evaluating Midodrine Hydrochloride for Hypotension, Orthostatic. Completed, enrolled 140 participants across 15 sites.
Detailed Summary
We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease. The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down and standing positions will be measured at each visit.