Trial Outcomes & Findings for Safety and Efficacy of L-NAME and Midodrine to Increase MAP (NCT NCT00835224)
NCT ID: NCT00835224
Last Updated: 2014-04-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration
Results posted on
2014-04-23
Participant Flow
34 subjects were consented 24 completed testing. Subjects were recruited through the Center of Excellence for the Medical Consequences of Spinal Cord Injury (SCI) from June 2010 to August of 2013.
Eligibility criteria were covered by the study coordinator prior to enrollment.
Participant milestones
| Measure |
All Participants
All Participants visited the laboratory on 3 occasions for a 4-5 hour observation of blood pressure following administration of a non-selective inhibitor of nitric oxide synthase (L-NAME) an alpha-agonist (midodrine) or placebo. The interventions were administered in random order on separate laboratory visits.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of L-NAME and Midodrine to Increase MAP
Baseline characteristics by cohort
| Measure |
All Participants
n=34 Participants
All participants were studied on three laboratory visits and underwent seated blood pressure assessment before and after administration of Midodrine, L-NAME or placebo, which were given in random order.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administrationOutcome measures
| Measure |
Arm 1A
n=15 Participants
Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
|
Arm 1B
n=10 Participants
Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
|
Arm 2A
n=15 Participants
Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
|
Arm 2B
n=10 Participants
Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
|
Arm 3A
n=15 Participants
Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
|
Arm 3B
n=10 Participants
Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
|
|---|---|---|---|---|---|---|
|
Blood Pressure
|
120 mmHg
Standard Deviation 17
|
112 mmHg
Standard Deviation 10
|
117 mmHg
Standard Deviation 19
|
109 mmHg
Standard Deviation 5
|
96 mmHg
Standard Deviation 12
|
109 mmHg
Standard Deviation 6
|
Adverse Events
Arm 1A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 1B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3B
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