A Phase 4 interventional study of Midodrine and Atomoxetine in Neurogenic Orthostatic Hypotension, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
Visit 1.
Questionnaire
Exclusion Criteria:
Atomoxetine 18mg once a day.
Drug: Atomoxetine
midodrine 2.5mg twice a day (increase to 5mg three times a day if necessary)
Drug: Midodrine
Midodrine single 5mg/day
Also known as: Midodrine only
Atomoxetine single 18mg/day
Also known as: Atomoxetine only
Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)
Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results. OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity. \*\* OHQ total score minimal 0 \~ maximal 100 (subscale OHDAS score minimal 0\~ maximal 40, OHSA score minimal 0\~ maximal 60)
Time frame: after 3-month medical treatment
Change in Orthostatic blood pressure Drop (mmHg)
Change of orthostatic Systolic blood pressure and Diastolic Blood Pressure drop after 3-month medical treatment compared to initial results.
Time frame: after 3-month medical treatment
Change of the Depression Score (Beck Depression Inventory-II )
Change of the depression score after 3-month medical treatment compared to initial results. 21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression. Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29- 63
Time frame: after 3-month medical treatment
Changes in Health-related Quality of Life
changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.
Time frame: after 3-month medical treatment
Plan to share: Undecided
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Seoul National University Hospital