Efficacy and Safety of Midodrine and Atomoxetine for Neurogenic OH
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|ClinicalTrials.gov Identifier: NCT03350659|
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neurogenic Orthostatic Hypotension||Drug: Midodrine Drug: Atomoxetine||Phase 4|
- Enroll, baseline evaluation of the patients
- Evaluate orthostatic hypotension symptom: Orthostatic Hypotension Questionnaire (OHQ)
- Quality of life: Korean version of Short-form 36
- Depressive symptom: Korean version of Beck Depression Inventory(BDI)-2
- Blood test (6cc): ELISA for alpha 1,2 and beta 1,2 adrenergic receptor antibody and nicotinic acetylcholine receptor antibody. Preserve sample for genetic testing.
- Randomization: randomize patients to three group in 1:1 ratio (Midodrine 5mg/day single, Atomoxetine 18mg/day single)
- Treatment education Visit 2. 1 month after treatment Orthostatic BP check/ check drug compliance and side effect/ Questionnaire If the patients meet BP criteria for OH, initiate combination treatment (Midodrine 5mg/day+Atomoxetine 18mg/day) Visit 3. 3 months after treatment Orthostatic BP check/ check drug compliance and side effect/ Questionnaire
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, open-label clinical trial.|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Midodrine and Atomoxetine Treatment in Patients With Neurogenic Orthostatic Hypotension : A Prospective Randomized Study|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||January 29, 2019|
|Actual Study Completion Date :||March 15, 2019|
Atomoxetine 18mg once a day.
Atomoxetine single 18mg/day
Other Name: Atomoxetine only
Active Comparator: Midodrine
midodrine 2.5mg twice a day (increase to 5mg three times a day if necessary)
Midodrine single 5mg/day
Other Name: Midodrine only
- Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ) [ Time Frame: after 3-month medical treatment ]
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)
- Change in Orthostatic blood pressure Drop (mmHg) [ Time Frame: after 3-month medical treatment ]Change of orthostatic Systolic blood pressure and Diastolic Blood Pressure drop after 3-month medical treatment compared to initial results.
- Change of the Depression Score (Beck Depression Inventory-II ) [ Time Frame: after 3-month medical treatment ]
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
- Changes in Health-related Quality of Life [ Time Frame: after 3-month medical treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350659
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 03080|
|Principal Investigator:||Chu Kon||Seoul National University Hospital|