Trial Outcomes & Findings for Prevention of Low Blood Pressure in Persons With Tetraplegia (NCT NCT00237770)
NCT ID: NCT00237770
Last Updated: 2014-05-19
Results Overview
Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
16 participants
Primary outcome timeframe
Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo.
Results posted on
2014-05-19
Participant Flow
Recruitment occured from January 2006 through May 2009; participants were recruited from the James J Peters VA Medical Center and the surrounding community.
No subject was excluded after enrollment prior to participation.
Participant milestones
| Measure |
Tetraplegic Subjects
All tetraplegic subjects underwent a head-up tilt maneuver to determine systolic blood pressure responses to placebo L-NAME 1.0 mg/kg and L-NAME 2.0 mg/kg. Subjects with tetraplegia visited the laboratory on 3 separate occasions.
|
Control Subjects
Systolic blood pressure responses to head-up tilt were determined in non-spinal cord injured control subjects following placebo administration. Control subjects visited the laboratory for 1 visit.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Low Blood Pressure in Persons With Tetraplegia
Baseline characteristics by cohort
| Measure |
Individuals With Tetraplegia
n=9 Participants
Systolic blood pressure responses to head-up tilt were determined after placebo, L-NAME (1.0 mg/kg) and L-NAME administration (2.0 mg/kg) administration.
|
Able-bodied Controls
n=7 Participants
Systolic blood pressure responses to head-up tilt were determined in able-bodied controls following placebo administration
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 10 • n=99 Participants
|
33 years
STANDARD_DEVIATION 9 • n=107 Participants
|
38 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
7 participants
n=107 Participants
|
16 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo.Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.
Outcome measures
| Measure |
Tetraplegic Systolic Blood Pressure Responses to Placebo
n=9 Participants
Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
|
Control Systolic Blood Pressure Responses to Placebo
n=7 Participants
Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
|
Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg
n=9 Participants
Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
|
Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg
n=9 Participants
Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
|
|---|---|---|---|---|
|
Systolic Blood Pressure During Head-up Tilt
|
91.80 mmHg
Standard Deviation 20.96
|
108.10 mmHg
Standard Deviation 12.18
|
112.04 mmHg
Standard Deviation 28.01
|
129.94 mmHg
Standard Deviation 26.43
|
Adverse Events
Tetraplegic Systolic Blood Pressure Responses to Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Systolic Blood Pressure Responses to Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg
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
Dr. Jill M. Wecht, principal Investigator
James J Peters VA Medical Center
Phone: 718 584-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place