Efficacy and Safety of Midodrine and Atomoxetine for Neurogenic OH

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Kyung Hee University Hospital at Gangdong
• Treatments: Atomoxetine Hydrochloride; Midodrine

Criteria

Inclusion Criteria:

• Age >=19 patients who complained of dizziness

• Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10

Exclusion Criteria:

• Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month

• Heart failure or Chronic renal failure

• Severe supine hypertension (Systolic Blood Pressure >180 or Diastolic Blood Pressure>110mmHg)

• Pregnant women, breast-feeding

• Unable to perform questionnaire