Trial Outcomes & Findings for Tilt-Table Study of the Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension (NCT NCT01518946)
NCT ID: NCT01518946
Last Updated: 2021-06-08
Results Overview
After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.
COMPLETED
PHASE4
24 participants
1 hour post-dose
2021-06-08
Participant Flow
Participant milestones
| Measure |
Midodrine HCl (Open-label Phase)
On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld.
|
Placebo First, Then Midodrine HCl (Randomized Phase)
Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
|
Midodrine HCl First, Then Placebo (Randomized Phase)
Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
|
|---|---|---|---|
|
Open-label Phase
STARTED
|
24
|
0
|
0
|
|
Open-label Phase
COMPLETED
|
20
|
0
|
0
|
|
Open-label Phase
NOT COMPLETED
|
4
|
0
|
0
|
|
Randomized Phase (First Intervention)
STARTED
|
0
|
10
|
10
|
|
Randomized Phase (First Intervention)
COMPLETED
|
0
|
9
|
10
|
|
Randomized Phase (First Intervention)
NOT COMPLETED
|
0
|
1
|
0
|
|
Randomized Phase (Second Intervention)
STARTED
|
0
|
9
|
10
|
|
Randomized Phase (Second Intervention)
COMPLETED
|
0
|
9
|
10
|
|
Randomized Phase (Second Intervention)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Midodrine HCl (Open-label Phase)
On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld.
|
Placebo First, Then Midodrine HCl (Randomized Phase)
Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
|
Midodrine HCl First, Then Placebo (Randomized Phase)
Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
|
|---|---|---|---|
|
Open-label Phase
Other
|
4
|
0
|
0
|
|
Randomized Phase (First Intervention)
Other
|
0
|
1
|
0
|
Baseline Characteristics
Tilt-Table Study of the Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
Baseline characteristics by cohort
| Measure |
Placebo First, Then Midodrine HCl (Randomized Phase)
n=10 Participants
Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
|
Midodrine HCl First, Then Placebo (Randomized Phase)
n=10 Participants
Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 19.52 • n=99 Participants
|
42.1 years
STANDARD_DEVIATION 18.64 • n=107 Participants
|
45.1 years
STANDARD_DEVIATION 18.82 • n=206 Participants
|
|
Age, Customized
18 to 65 years, inclusive
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Customized
>= 66 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hour post-dosePopulation: The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of randomized investigational product and who had at least 1 measurement of the time to onset of syncopal symptoms/near syncope during tilt-table testing.
After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.
Outcome measures
| Measure |
Placebo
n=19 Participants
single dose of matching placebo
|
Midodrine HCl
n=19 Participants
dose at the subject's current dose level
|
|---|---|---|
|
Time to Onset of Syncope/Near Syncope While on Tilt Table
|
1105.6 seconds
Standard Error 186.82
|
1626.6 seconds
Standard Error 186.82
|
Adverse Events
Midodrine HCl (Open-label Phase)
Placebo (Randomized Phase)
Midodrine HCl (Randomized Phase)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Midodrine HCl (Open-label Phase)
n=24 participants at risk
dose at the subject's current dose level
|
Placebo (Randomized Phase)
n=20 participants at risk
single dose of matching placebo
|
Midodrine HCl (Randomized Phase)
n=20 participants at risk
dose at the subject's current dose level
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Number of events 2
|
0.00%
0/20
|
0.00%
0/20
|
|
General disorders
Fatigue
|
0.00%
0/24
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/24
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2
|
0.00%
0/20
|
0.00%
0/20
|
|
Vascular disorders
Flushing
|
0.00%
0/24
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hot Flush
|
0.00%
0/24
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
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