Trial Outcomes & Findings for A Study for Patients With Neurogenic Orthostatic Hypotension (NCT NCT00046475)
NCT ID: NCT00046475
Last Updated: 2021-06-11
Results Overview
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.
COMPLETED
PHASE4
140 participants
End of 2-week treatment period
2021-06-11
Participant Flow
Patients who completed the Titration Period were then randomized to receive either Midodrine/Placebo or Placebo/Midodrine during Treatment Periods 1 and 2. Some patients did not meet the criteria for randomization, had an AE, or withdrew from the study after completing the Titration Period prior to entering Treatment Period 1.
Participant milestones
| Measure |
All Enrolled Participants
All patients who were enrolled in this study are included in this population.
|
Midodrine/Placebo
Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
|
Placebo/Midodrine
Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
|
|---|---|---|---|
|
Screening/Washout Period (Up to 2 Weeks)
STARTED
|
140
|
0
|
0
|
|
Screening/Washout Period (Up to 2 Weeks)
COMPLETED
|
136
|
0
|
0
|
|
Screening/Washout Period (Up to 2 Weeks)
NOT COMPLETED
|
4
|
0
|
0
|
|
Titration (1 Week)
STARTED
|
136
|
0
|
0
|
|
Titration (1 Week)
COMPLETED
|
136
|
0
|
0
|
|
Titration (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 1 (Up to 2 Weeks)
STARTED
|
0
|
45
|
60
|
|
Treatment Period 1 (Up to 2 Weeks)
COMPLETED
|
0
|
45
|
59
|
|
Treatment Period 1 (Up to 2 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
|
Treatment Period 2 (Up to 2 Weeks)
STARTED
|
0
|
45
|
59
|
|
Treatment Period 2 (Up to 2 Weeks)
COMPLETED
|
0
|
44
|
59
|
|
Treatment Period 2 (Up to 2 Weeks)
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study for Patients With Neurogenic Orthostatic Hypotension
Baseline characteristics by cohort
| Measure |
Midodrine/Placebo
n=45 Participants
Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
|
Placebo/Midodrine
n=59 Participants
Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 14.22 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 14.43 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 14.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of 2-week treatment periodPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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.
Outcome measures
| Measure |
Midodrine HCl
n=103 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=103 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Post-treatment Score For Item 1 of The Orthostatic Hypotension Symptom Assessment (OHSA) Scale
|
4.1 scores on a scale
Standard Deviation 2.9
|
5.2 scores on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: End of 2-week treatment periodPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement. Data for 2 sites were excluded from this re-analysis.
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.
Outcome measures
| Measure |
Midodrine HCl
n=94 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=94 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Re-analysis of The Post-treatment Score For Item 1 of The OHSA Scale, Excluding Two Sites
|
4.3 scores on a scale
Standard Deviation 2.93
|
5.1 scores on a scale
Standard Deviation 2.76
|
PRIMARY outcome
Timeframe: End of 2-week treatment periodPopulation: Randomized participants enrolled at any of the 28 US sites
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. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Mild or Moderate disease severity. Higher scores indicate more severe disease.
Outcome measures
| Measure |
Midodrine HCl
n=39 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=39 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Post-treatment OHSA Item 1 Score of United States (US) Participants With Mild/Moderate Disease According to The Clinical Global Impressions-Severity (CGI-S) Scale
|
4.4 scores on a scale
Standard Deviation 2.97
|
3.8 scores on a scale
Standard Deviation 2.63
|
PRIMARY outcome
Timeframe: End of 2-week treatment periodPopulation: Randomized participants enrolled at any of the 28 US sites
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. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Marked or Severe disease severity. Higher scores indicate more severe disease.
Outcome measures
| Measure |
Midodrine HCl
n=30 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=30 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Post-treatment OHSA Item 1 Score of US Participants With Marked/Severe Disease According to The CGI-S Scale
|
4.7 scores on a scale
Standard Deviation 2.90
|
6.1 scores on a scale
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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 baseline indicates that symptoms have improved.
Outcome measures
| Measure |
Midodrine HCl
n=103 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=103 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Change From Baseline in The OHSA Items 2 Through 6 Scores
Item 2, n= 103, 103
|
-1.2 scores on a scale
Standard Deviation 2.5
|
-0.2 scores on a scale
Standard Deviation 2.3
|
|
Change From Baseline in The OHSA Items 2 Through 6 Scores
Item 3, n=103, 103
|
-1.3 scores on a scale
Standard Deviation 3.2
|
-0.4 scores on a scale
Standard Deviation 2.5
|
|
Change From Baseline in The OHSA Items 2 Through 6 Scores
Item 4, n=103, 103
|
-1.2 scores on a scale
Standard Deviation 3.2
|
-0.4 scores on a scale
Standard Deviation 2.6
|
|
Change From Baseline in The OHSA Items 2 Through 6 Scores
Item 5, n=102, 102
|
-0.4 scores on a scale
Standard Deviation 2.7
|
0.0 scores on a scale
Standard Deviation 2.2
|
|
Change From Baseline in The OHSA Items 2 Through 6 Scores
Item 6, n=102, 102
|
-0.8 scores on a scale
Standard Deviation 2.6
|
-0.5 scores on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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 (study completion). A negative change from baseline indicates that symptoms have improved.
Outcome measures
| Measure |
Midodrine HCl
n=102 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=102 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Change From Baseline in The OHSA Composite Symptom Score
|
-1.3 scores on a scale
Standard Deviation 2.5
|
-0.54 scores on a scale
Standard Deviation 1.952
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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.
Outcome measures
| Measure |
Midodrine HCl
n=104 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=104 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 Scores
Item 1, n=102, 101
|
-1.1 scores on a scale
Standard Deviation 2.90
|
-0.4 scores on a scale
Standard Deviation 1.95
|
|
Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 Scores
Item 2, n=98, 99
|
-1.8 scores on a scale
Standard Deviation 3.14
|
-0.6 scores on a scale
Standard Deviation 2.41
|
|
Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 Scores
Item 3, n=100, 101
|
-1.1 scores on a scale
Standard Deviation 2.71
|
-0.2 scores on a scale
Standard Deviation 2.16
|
|
Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 Scores
Item 4, n=89, 90
|
-1.3 scores on a scale
Standard Deviation 3.31
|
-0.5 scores on a scale
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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.
Outcome measures
| Measure |
Midodrine HCl
n=103 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=103 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Change From Baseline in The Orthostatic Hypotension Global Daily Activity Score
|
-1.4 scores on a scale
Standard Deviation 2.6
|
-0.4 scores on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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).
Outcome measures
| Measure |
Midodrine HCl
n=104 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=104 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Percent of Participants Scored as Improved on The Clinician Version of The Clinical Global Impressions Improvement (CGI-I) Scale
|
73.1 percent of participants
|
45.2 percent of participants
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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).
Outcome measures
| Measure |
Midodrine HCl
n=104 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=104 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Percent of Participants Scored as Improved on The Patient Version of The CGI-I Scale
|
62.5 percent of participants
|
50.0 percent of participants
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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.
Outcome measures
| Measure |
Midodrine HCl
n=104 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=104 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Change From Baseline in Standing Blood Pressure (BP)
Systolic Pressure
|
10.7 mmHg
Standard Deviation 21.68
|
2.8 mmHg
Standard Deviation 19.55
|
|
Change From Baseline in Standing Blood Pressure (BP)
Diastolic Pressure
|
5.9 mmHg
Standard Deviation 14.46
|
1.5 mmHg
Standard Deviation 13.03
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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.
Outcome measures
| Measure |
Midodrine HCl
n=104 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=104 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Change From Baseline in Supine BP
Systolic Pressure
|
7.6 mmHg
Standard Deviation 22.76
|
-0.9 mmHg
Standard Deviation 15.74
|
|
Change From Baseline in Supine BP
Diastolic Pressure
|
3.4 mmHg
Standard Deviation 11.89
|
0.3 mmHg
Standard Deviation 10.35
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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).
Outcome measures
| Measure |
Midodrine HCl
n=70 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
n=69 Participants
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Version 2 Health Survey Questionnaire Scores
General Health
|
1.97 scores on a scale
Standard Deviation 7.801
|
1.59 scores on a scale
Standard Deviation 6.027
|
|
Change From Baseline in Short Form-36 (SF-36) Version 2 Health Survey Questionnaire Scores
Physical Functioning
|
1.99 scores on a scale
Standard Deviation 8.255
|
1.71 scores on a scale
Standard Deviation 8.034
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
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.
Outcome measures
| Measure |
Midodrine HCl
n=59 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Test Reliability of the Intent-to-Treat (ITT) Population
OHSA Item 1
|
0.53 correlation coefficient
|
—
|
|
Test Reliability of the Intent-to-Treat (ITT) Population
OHSA Composite Score
|
0.61 correlation coefficient
|
—
|
|
Test Reliability of the Intent-to-Treat (ITT) Population
OHDAS Global Daily Activity Score
|
0.66 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for responsiveness as a measure of validity. Assuming that subjects who received Placebo during Randomization Period 1 are stable between Visit 3A and Visit 5, and using them as the stable subjects, responsiveness was calculated as \[(OH CFB in Midodrine group)-(OH CFB in Placebo group)\]/(SD of OH CFB in Placebo group), where CFB is change from baseline, SD is the standard deviation of OH CFB of the stable subjects; the value reported is the quotient of this equation.
Outcome measures
| Measure |
Midodrine HCl
n=59 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Responsiveness of the Intent-to-Treat (ITT) Population
OHSA Item 1
|
-0.4099 quotient
|
—
|
|
Responsiveness of the Intent-to-Treat (ITT) Population
OHSA Composite Score
|
-0.4014 quotient
|
—
|
|
Responsiveness of the Intent-to-Treat (ITT) Population
OHDAS Global Daily Activity Score
|
-0.4903 quotient
|
—
|
SECONDARY outcome
Timeframe: From the time of titration until the end of treatmentPopulation: Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
Item 1 of the OHSA and the OHSA composite score were analyzed for convergent validity with the CGI-I-Clinician scores. The change from baseline in the CGI-I scores are correlated with the OHSA Item 1 score change from baseline and the OHSA composite score change from baseline for the subjects in the ITT population. Values shown are Spearman correlation coefficients.
Outcome measures
| Measure |
Midodrine HCl
n=104 Participants
Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
|
Placebo
Participants received Placebo daily for 2 weeks
|
|---|---|---|
|
Convergent Validity of the Intent-to-Treat (ITT) Population
OHSA Item 1, n=103
|
0.36 correlation coefficient
|
—
|
|
Convergent Validity of the Intent-to-Treat (ITT) Population
OHSA Composite Score, n=102
|
0.38 correlation coefficient
|
—
|
Adverse Events
Screening/Washout
Titration
Midodrine HCl
Placebo
Follow-up
Serious adverse events
| Measure |
Screening/Washout
n=140 participants at risk
Patients signed the informed consent form and were screened for eligibility. Eligible patients were off drug for 1 week.
|
Titration
n=136 participants at risk
Patients received different doses of drug for at least 2 weeks to determine the maximum tolerated dose.
|
Midodrine HCl
n=104 participants at risk
Patients received their optimum dose of Midodrine HCl for 2 weeks.
|
Placebo
n=105 participants at risk
Patients received Placebo for 2 weeks.
|
Follow-up
n=140 participants at risk
Patients were contacted 30 days after last study drug dose to follow up on any ongoing AEs and inquire if there were any new AEs.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/140
|
0.00%
0/136
|
0.00%
0/104
|
0.00%
0/105
|
0.71%
1/140
|
|
Eye disorders
Blindness cortical
|
0.00%
0/140
|
0.74%
1/136
|
0.00%
0/104
|
0.00%
0/105
|
0.00%
0/140
|
|
Gastrointestinal disorders
Colitis NOS
|
0.00%
0/140
|
0.00%
0/136
|
0.00%
0/104
|
0.00%
0/105
|
0.71%
1/140
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage NOS
|
0.00%
0/140
|
0.00%
0/136
|
0.00%
0/104
|
0.00%
0/105
|
0.71%
1/140
|
|
Injury, poisoning and procedural complications
Injury NOS
|
0.00%
0/140
|
0.00%
0/136
|
0.00%
0/104
|
0.00%
0/105
|
0.71%
1/140
|
|
Injury, poisoning and procedural complications
Therapeutic agent poisoning
|
0.00%
0/140
|
0.74%
1/136
|
0.00%
0/104
|
0.00%
0/105
|
0.00%
0/140
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/140
|
0.00%
0/136
|
0.00%
0/104
|
0.95%
1/105
|
0.00%
0/140
|
|
Nervous system disorders
Convulsions NOS
|
0.00%
0/140
|
0.74%
1/136
|
0.00%
0/104
|
0.00%
0/105
|
0.00%
0/140
|
|
Nervous system disorders
Parkinson's disease NOS
|
0.00%
0/140
|
0.00%
0/136
|
0.00%
0/104
|
0.00%
0/105
|
0.71%
1/140
|
|
Nervous system disorders
Syncope
|
0.00%
0/140
|
0.00%
0/136
|
0.00%
0/104
|
0.00%
0/105
|
0.71%
1/140
|
|
Vascular disorders
Orthostatic hypotension
|
0.71%
1/140
|
0.74%
1/136
|
0.00%
0/104
|
0.00%
0/105
|
0.71%
1/140
|
Other adverse events
| Measure |
Screening/Washout
n=140 participants at risk
Patients signed the informed consent form and were screened for eligibility. Eligible patients were off drug for 1 week.
|
Titration
n=136 participants at risk
Patients received different doses of drug for at least 2 weeks to determine the maximum tolerated dose.
|
Midodrine HCl
n=104 participants at risk
Patients received their optimum dose of Midodrine HCl for 2 weeks.
|
Placebo
n=105 participants at risk
Patients received Placebo for 2 weeks.
|
Follow-up
n=140 participants at risk
Patients were contacted 30 days after last study drug dose to follow up on any ongoing AEs and inquire if there were any new AEs.
|
|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection NOS
|
3.6%
5/140
|
4.4%
6/136
|
0.96%
1/104
|
0.95%
1/105
|
5.0%
7/140
|
|
Nervous system disorders
Dizziness
|
2.1%
3/140
|
5.1%
7/136
|
2.9%
3/104
|
4.8%
5/105
|
3.6%
5/140
|
|
Nervous system disorders
Headache NOS
|
0.71%
1/140
|
9.6%
13/136
|
5.8%
6/104
|
6.7%
7/105
|
3.6%
5/140
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/140
|
7.4%
10/136
|
4.8%
5/104
|
4.8%
5/105
|
2.1%
3/140
|
|
Skin and subcutaneous tissue disorders
Pruritus NOS
|
0.00%
0/140
|
8.1%
11/136
|
7.7%
8/104
|
7.6%
8/105
|
6.4%
9/140
|
|
Vascular disorders
Hypertension NOS
|
2.9%
4/140
|
6.6%
9/136
|
2.9%
3/104
|
1.9%
2/105
|
1.4%
2/140
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER