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Efficacy and Safety of Midodrine and Atomoxetine for Neurogenic OH

NCT03350659 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-04-05

No results posted yet for this study

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.

Conditions

  • Neurogenic Orthostatic Hypotension

Interventions

DRUG

Midodrine

Midodrine single 5mg/day

DRUG

Atomoxetine

Atomoxetine single 18mg/day

Sponsors & Collaborators

  • Kyung Hee University Hospital at Gangdong

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Chu Kon · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-01-29
Completion
2019-03-15

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350659 on ClinicalTrials.gov