CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Midodrine +1 moredrug
Likely dose
Midodrine 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/NCT03350659
NCT03350659Phase 4Completed
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Efficacy and Safety of Midodrine and Atomoxetine Treatment in Patients With Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

Seoul National University Hospital·interventional·Posted Nov 22, 2017·Updated Apr 5, 2019

In Brief

A Phase 4 clinical trial evaluating Midodrine and Atomoxetine for Neurogenic Orthostatic Hypotension. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This was a randomized, open-label clinical trial. We will enroll patients with symptomatic neurogenic OH and randomize them to 1 of 2 treatments: (1) midodrine only, (2) atomoxetine only. We will follow up patients at 1 and 3 months after treatment. If the patients meet BP criteria for OH at 1 month, they will receive combination treatment with both midodrine and atomoxetin. The primary outcome measure is amelioration of questionnaire score evaluating OH-associated symptoms at 3 months. Secondary end-points were improvement in orthostatic blood pressure (BP) drop at 1 and 3 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurogenic Orthostatic Hypotension
CountriesSouth Korea
CollaboratorsKyung Hee University Hospital at Gangdong

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 22, 2017
Enrollment StartJan 1, 2018
Primary CompletionJan 29, 2019
Study CompletionMar 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.6 years ago

Interventions

Midodrinedrug

Midodrine single 5mg/day

Atomoxetinedrug

Atomoxetine single 18mg/day