Trial Outcomes & Findings for A Dose Response Trial Using 5 and 10 Mg of Midodrine Hydrochloride (NCT NCT00426842)
NCT ID: NCT00426842
Last Updated: 2016-10-10
Results Overview
brachial artery systolic blood pressure (mmHg)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
The difference between the average supine systolic blood pressure and the average systolic blood pressure at 45 degree head-up tilt position.
Results posted on
2016-10-10
Participant Flow
2008-2010
no subject was excluded from study participate prior to group assignment.
Participant milestones
| Measure |
All Participants
All participants underwent a head-up tilt maneuver following no-drug, midodrine 5 mg and midodrine 10 mg, in that order, on seperate study visits. Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants
All participants underwent a head-up tilt maneuver following no-drug, midodrine 5 mg and midodrine 10 mg, in that order, on seperate study visits. Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Dose Response Trial Using 5 and 10 Mg of Midodrine Hydrochloride
Baseline characteristics by cohort
| Measure |
Arm 1
n=11 Participants
Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The difference between the average supine systolic blood pressure and the average systolic blood pressure at 45 degree head-up tilt position.brachial artery systolic blood pressure (mmHg)
Outcome measures
| Measure |
No-drug
n=11 Participants
|
Midodrine 5 mg
n=10 Participants
|
Midodrine 10 mg
n=10 Participants
|
|---|---|---|---|
|
Systolic Blood Pressure
Baseline Blood Pressure
|
98 mmHg
Standard Deviation 5
|
97 mmHg
Standard Deviation 5
|
102 mmHg
Standard Deviation 12
|
|
Systolic Blood Pressure
Head-up Tilt Blood Pressure
|
87 mmHg
Standard Deviation 15
|
96 mmHg
Standard Deviation 19
|
109 mmHg
Standard Deviation 22
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place