At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 66 enrolled

Drug / intervention

Midodrine Hydrochloride +1 moredrug

Likely dose

Midodrine Hydrochloride 5mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02919917

NCT02919917Phase 3Completed

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Treatment of Post-SCI Hypotension: A Randomized Controlled Study of Usual Care Versus Anti Hypotension Therapy

James J. Peters Veterans Affairs Medical Center·interventional·Posted Sep 30, 2016·Updated Feb 21, 2025

In Brief

A Phase 3 clinical trial evaluating Midodrine Hydrochloride for Spinal Cord Injury and 9 related conditions. Completed, enrolled 66 participants across 2 sites.

Detailed Summary

While treatment strategies for OH have been identified for use in persons with acute SCI, the field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome parameters. Comprehensively documenting the impact of orthostatic hypotension (OH), regardless of symptoms, during acute rehabilitation and identifying the effects of two different treatment approaches on therapy participation and adherence to an intended rehabilitation plan could have a significant impact on clinical practice in the acute rehabilitation setting following SCI.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSpinal Cord Injury, Autonomic Dysreflexia, Orthostatic Hypotension, Baroreceptor Integrity, Sympathetic Integrity, Vagal Integrity, Hypotension, Cerebral Blood Flow, Blood Pressure, Venous Occlusion Plethysmography

CountriesUnited States

CollaboratorsIcahn School of Medicine at Mount Sinai

Timeline

Phase 3CompletedFinished

2017201820192020202120222023202420252026

First PostedSep 2016

Enrollment StartJun 2017

Primary CompletionSep 2021

TodayJul 2026

First PostedSep 30, 2016

Enrollment StartJun 1, 2017

Primary CompletionSep 1, 2021

TodayJul 2, 2026

Enrollment to primary: 4.3 yearsPosted 9.8 years ago

Interventions

Midodrine Hydrochloridedrug

Level 1: Compression stockings, abdominal binder Level 2: Midodrine 5mg 2x/d Level 3: Midodrine 10mg 2x/d Level 4: Midodrine 15mg 2x/d Level 5: Midodrine 20mg 2x/d Level 6 Midodrine 20mg 2x/d and Fludrocortisone 0.1mg 2x/d Level 7 Midodrine 20mg 2x/d and Fludrocortisone 0.2mg 2x/d

Midodrine Hydrochloridedrug