18 and older, any sex, with Hypotension, Orthostatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Post-treatment Score For Item 1 of The Orthostatic Hypotension Symptom Assessment (OHSA) ScalePrimary· End of 2-week treatment period
Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.
Group
Value
95% CI
Midodrine HCl
4.1
± 2.9
Placebo
5.2
± 2.7
Re-analysis of The Post-treatment Score For Item 1 of The OHSA Scale, Excluding Two SitesPrimary· End of 2-week treatment period
Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.
Group
Value
95% CI
Midodrine HCl
4.3
± 2.93
Placebo
5.1
± 2.76
Change From Baseline in The OHSA Items 2 Through 6 ScoresSecondary· From the time of titration until the end of treatment
Items 2 through 6 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of the following symptoms whenever he or she was standing and that improved when he or she sat down or laid down: Item 2 addresses problems with vision (blurring, seeing spots, tunnel vision, etc); Item 3, weakness; Item 4, fatigue; Item 5, trouble concentrating; and Item 6, head or neck discomfort. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseli
Item 2, n= 103, 103
Group
Value
95% CI
Midodrine HCl
-1.2
± 2.5
Placebo
-0.2
± 2.3
Item 3, n=103, 103
Group
Value
95% CI
Midodrine HCl
-1.3
± 3.2
Placebo
-0.4
± 2.5
Item 4, n=103, 103
Group
Value
95% CI
Midodrine HCl
-1.2
± 3.2
Placebo
-0.4
± 2.6
Item 5, n=102, 102
Group
Value
95% CI
Midodrine HCl
-0.4
± 2.7
Placebo
0.0
± 2.2
Item 6, n=102, 102
Group
Value
95% CI
Midodrine HCl
-0.8
± 2.6
Placebo
-0.5
± 2.1
Change From Baseline in The OHSA Composite Symptom ScoreSecondary· From the time of titration until the end of treatment
The OHSA composite symptom score was calculated by taking the average of the ratings for the symptoms present at Baseline. Participants were asked to rate symptoms by using a 0-10 scale (0 meaning not bothered and 10 meaning the worst). For subsequent visits, only those symptoms present at Baseline were scored. In this manner, a score was produced that represents the severity (and subsequent change in severity) of the patient's neurogenic OH symptoms, regardless of how many symptoms are presented at Baseline. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6
Group
Value
95% CI
Midodrine HCl
-1.3
± 2.5
Placebo
-0.54
± 1.952
Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 ScoresSecondary· From the time of titration until the end of treatment
The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH). Item 1 addressed activities that required standing for a short time; Item 2, activities that required standing for a long time; Item 3, activities that required walking for a short time; and Item 4, activities that required walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.
Item 1, n=102, 101
Group
Value
95% CI
Midodrine HCl
-1.1
± 2.90
Placebo
-0.4
± 1.95
Item 2, n=98, 99
Group
Value
95% CI
Midodrine HCl
-1.8
± 3.14
Placebo
-0.6
± 2.41
Item 3, n=100, 101
Group
Value
95% CI
Midodrine HCl
-1.1
± 2.71
Placebo
-0.2
± 2.16
Item 4, n=89, 90
Group
Value
95% CI
Midodrine HCl
-1.3
± 3.31
Placebo
-0.5
± 2.57
Change From Baseline in The Orthostatic Hypotension Global Daily Activity ScoreSecondary· From the time of titration until the end of treatment
The OHDAS global daily activity score was calculated as the average of all daily activity item scores. The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH) to activities that required standing for a short time, standing for a long time, walking for a short time, walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.
Group
Value
95% CI
Midodrine HCl
-1.4
± 2.6
Placebo
-0.4
± 1.9
Percent of Participants Scored as Improved on The Clinician Version of The Clinical Global Impressions Improvement (CGI-I) ScaleSecondary· From the time of titration until the end of treatment
The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of "Overall Improvement." The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion).
Group
Value
95% CI
Midodrine HCl
73.1
Placebo
45.2
Percent of Participants Scored as Improved on The Patient Version of The CGI-I ScaleSecondary· From the time of titration until the end of treatment
The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of "Overall Improvement." The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion).
Group
Value
95% CI
Midodrine HCl
62.5
Placebo
50.0
Change From Baseline in Standing Blood Pressure (BP)Secondary· From the time of titration until the end of treatment
Standing BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Standing BP was measured 3 minutes after the patient rose from the supine position or as soon as the patient indicated they needed to sit down. If the patient indicated he or she needed to sit down, the BP measurement was taken while in the standing position, before the patient sat down.
Systolic Pressure
Group
Value
95% CI
Midodrine HCl
10.7
± 21.68
Placebo
2.8
± 19.55
Diastolic Pressure
Group
Value
95% CI
Midodrine HCl
5.9
± 14.46
Placebo
1.5
± 13.03
Change From Baseline in Supine BPSecondary· From the time of titration until the end of treatment
Supine BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Supine BP was measured after the patient had been in the supine position for 5 minutes.
Systolic Pressure
Group
Value
95% CI
Midodrine HCl
7.6
± 22.76
Placebo
-0.9
± 15.74
Diastolic Pressure
Group
Value
95% CI
Midodrine HCl
3.4
± 11.89
Placebo
0.3
± 10.35
Change From Baseline in Short Form-36 (SF-36) Version 2 Health Survey Questionnaire ScoresSecondary· From the time of titration until the end of treatment
The SF-36 consists of 36 items in eight domains: physical functioning, general health, role-physical, bodily pain, vitality, social functioning, role-emotional, and mental health. Version 2 references "one week ago" for some questions. Raw scale scores for the SF-36 were transformed to a 0-100 scale with a higher score indicating a better quality of life. A positive change from baseline indicates that symptoms have improved. The SF-36 was completed at Visit 5 (Period 2) and Visit 6 (study completion) and compared to the score from Visit 3A (titration).
General Health
Group
Value
95% CI
Midodrine HCl
1.97
± 7.801
Placebo
1.59
± 6.027
Physical Functioning
Group
Value
95% CI
Midodrine HCl
1.99
± 8.255
Placebo
1.71
± 8.034
Test Reliability of the Intent-to-Treat (ITT) PopulationSecondary· From the time of titration until the end of treatment
Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for test-retest reliability as a measure of validity. Test-retest reliability is the Pearson product-moment correlation coefficient calculated between OHQ scores at Visit 3A (baseline measure) and OHQ scores at Visit 5 for the subjects who received Placebo during Randomization Period 1.
OHSA Item 1
Group
Value
95% CI
ITT Population
0.53
OHSA Composite Score
Group
Value
95% CI
ITT Population
0.61
OHDAS Global Daily Activity Score
Group
Value
95% CI
ITT Population
0.66
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease.
The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down and standing positions will be measured at each visit.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 11 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00046475.