Trial Outcomes & Findings for A Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia (NCT NCT02164981)
NCT ID: NCT02164981
Last Updated: 2018-10-02
Results Overview
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
For Phase 1, timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28
Results posted on
2018-10-02
Participant Flow
Per the Sequential Parallel Comparison Design, the 18 subjects in the SNP-SNP group were excluded from Phase 2 analyses. There were no Phase 1 placebo responders, so no exclusions were made based on this SPCD criterion. Ph 1 (N=52): all groups; Ph 2 (N=34): (Placebo)-Placebo (N=18), (SNP)-Placebo (N=16). All subjects were followed for 28 days.
Participant milestones
| Measure |
Drug - Drug
Phase 1 - intravenous sodium Nitroprusside (Drug) Phase 2 - intravenous sodium Nitroprusside (Drug)
Subjects will receive i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 0 (Phase 1) and Day 14 (Phase 2)
|
Placebo - Drug
Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous sodium Nitroprusside (Drug)
Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 14 (Phase 2)
|
Placebo - Placebo
Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous dextrose (Placebo)
Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and again at Day 14 (Phase 2).
|
|---|---|---|---|
|
Started
STARTED
|
23
|
19
|
18
|
|
Started
COMPLETED
|
18
|
16
|
18
|
|
Started
NOT COMPLETED
|
5
|
3
|
0
|
|
Phase 1 (Day 0 - Day 14)
STARTED
|
18
|
16
|
18
|
|
Phase 1 (Day 0 - Day 14)
COMPLETED
|
18
|
14
|
18
|
|
Phase 1 (Day 0 - Day 14)
NOT COMPLETED
|
0
|
2
|
0
|
|
Phase 2 (Day 14 - Day 28)
STARTED
|
18
|
14
|
18
|
|
Phase 2 (Day 14 - Day 28)
COMPLETED
|
16
|
12
|
18
|
|
Phase 2 (Day 14 - Day 28)
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Drug - Drug
Phase 1 - intravenous sodium Nitroprusside (Drug) Phase 2 - intravenous sodium Nitroprusside (Drug)
Subjects will receive i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 0 (Phase 1) and Day 14 (Phase 2)
|
Placebo - Drug
Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous sodium Nitroprusside (Drug)
Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 14 (Phase 2)
|
Placebo - Placebo
Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous dextrose (Placebo)
Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and again at Day 14 (Phase 2).
|
|---|---|---|---|
|
Started
Withdrawal by Subject
|
2
|
1
|
0
|
|
Started
Protocol Violation
|
2
|
0
|
0
|
|
Started
Adverse Event
|
1
|
2
|
0
|
|
Phase 1 (Day 0 - Day 14)
Adverse Event
|
0
|
2
|
0
|
|
Phase 2 (Day 14 - Day 28)
Adverse Event
|
2
|
1
|
0
|
|
Phase 2 (Day 14 - Day 28)
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
A Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia
Baseline characteristics by cohort
| Measure |
Drug - Drug
n=18 Participants
Phase 1 - intravenous sodium Nitroprusside (Drug) Phase 2 - intravenous sodium Nitroprusside (Drug)
Subjects will receive i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 0 (Phase 1) and Day 14 (Phase 2)
|
Placebo - Drug
n=16 Participants
Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous sodium Nitroprusside (Drug)
Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 14 (Phase 2)
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous dextrose (Placebo)
Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and again at Day 14 (Phase 2).
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 10.5 • n=93 Participants
|
45.9 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
40.4 years
STANDARD_DEVIATION 11.0 • n=27 Participants
|
44.5 years
STANDARD_DEVIATION 11.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
48 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
52 Participants
n=483 Participants
|
|
The Positive and Negative Syndrome Scale (PANSS) at Baseline (Day 3)
PANSS -total
|
83.6 units on a scale
STANDARD_DEVIATION 10.0 • n=93 Participants
|
77.6 units on a scale
STANDARD_DEVIATION 8.8 • n=4 Participants
|
81.7 units on a scale
STANDARD_DEVIATION 8.8 • n=27 Participants
|
80.9 units on a scale
STANDARD_DEVIATION 9.2 • n=483 Participants
|
|
The Positive and Negative Syndrome Scale (PANSS) at Baseline (Day 3)
PANSS - positive
|
24.9 units on a scale
STANDARD_DEVIATION 3.5 • n=93 Participants
|
22.3 units on a scale
STANDARD_DEVIATION 3.4 • n=4 Participants
|
22.6 units on a scale
STANDARD_DEVIATION 3.1 • n=27 Participants
|
23.26 units on a scale
STANDARD_DEVIATION 3.3 • n=483 Participants
|
|
The Positive and Negative Syndrome Scale (PANSS) at Baseline (Day 3)
PANSS - negative
|
20.9 units on a scale
STANDARD_DEVIATION 5.5 • n=93 Participants
|
20.3 units on a scale
STANDARD_DEVIATION 5.0 • n=4 Participants
|
21.4 units on a scale
STANDARD_DEVIATION 4.6 • n=27 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 15.1 • n=483 Participants
|
PRIMARY outcome
Timeframe: For Phase 1, timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2
Phase 1 - Total Score - Baseline
|
83.6 units on a scale
Standard Deviation 10.0
|
79.8 units on a scale
Standard Deviation 8.9
|
—
|
|
Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2
Phase 1 - Total Score - Day 14
|
77.6 units on a scale
Standard Deviation 12.2
|
76.7 units on a scale
Standard Deviation 11.0
|
—
|
|
Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2
Phase 1 - Total Score - Change
|
-6.0 units on a scale
Standard Deviation 11.3
|
-2.5 units on a scale
Standard Deviation 7.1
|
—
|
|
Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2
Phase 2 - Total Score - Day 14
|
74.0 units on a scale
Standard Deviation 12.0
|
78.8 units on a scale
Standard Deviation 10.1
|
—
|
|
Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2
Phase 2 - Total Score - Day 28
|
71.8 units on a scale
Standard Deviation 10.6
|
74.7 units on a scale
Standard Deviation 9.0
|
—
|
|
Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2
Phase 2 - Total Score - Change
|
-1.8 units on a scale
Standard Deviation 8.2
|
-4.2 units on a scale
Standard Deviation 6.4
|
—
|
SECONDARY outcome
Timeframe: Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 22 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Positive scale: 7 Items, (minimum score = 7, maximum score = 49)
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
PANSS - Positive Subscale - Phases 1 and 2
Phase 1 - Positive Score - Baseline
|
24.5 units on a scale
Standard Deviation 3.5
|
22.3 units on a scale
Standard Deviation 3.1
|
—
|
|
PANSS - Positive Subscale - Phases 1 and 2
Phase 1 - Positive Score - Day 14
|
23.1 units on a scale
Standard Deviation 4.6
|
21.3 units on a scale
Standard Deviation 3.6
|
—
|
|
PANSS - Positive Subscale - Phases 1 and 2
Phase 1 - Positive Score - Change
|
-1.8 units on a scale
Standard Deviation 1.8
|
-0.81 units on a scale
Standard Deviation 2.7
|
—
|
|
PANSS - Positive Subscale - Phases 1 and 2
Phase 2 - Positive Score - Day 14
|
20.7 units on a scale
Standard Deviation 3.6
|
21.8 units on a scale
Standard Deviation 3.6
|
—
|
|
PANSS - Positive Subscale - Phases 1 and 2
Phase 2 - Positive Score - Day 28
|
21.3 units on a scale
Standard Deviation 4.6
|
22.3 units on a scale
Standard Deviation 3.4
|
—
|
|
PANSS - Positive Subscale - Phases 1 and 2
Phase 2 - Positive Score - Change
|
0.5 units on a scale
Standard Deviation 3.8
|
0.5 units on a scale
Standard Deviation 2.17
|
—
|
SECONDARY outcome
Timeframe: Phase 1 timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Negative scale: 7 Items, (minimum score = 7, maximum score = 49)
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
PANSS - Negative Subscale - Phases 1 and 2
Phase 2 - Negative Score - Day 28
|
18.0 units on a scale
Standard Deviation 6.2
|
19.8 units on a scale
Standard Deviation 4.7
|
—
|
|
PANSS - Negative Subscale - Phases 1 and 2
Phase 1 - Negative Score - Baseline
|
20.8 units on a scale
Standard Deviation 5.8
|
20.6 units on a scale
Standard Deviation 4.8
|
—
|
|
PANSS - Negative Subscale - Phases 1 and 2
Phase 1 - Negative Score - Day 14
|
19.0 units on a scale
Standard Deviation 4.6
|
19.7 units on a scale
Standard Deviation 5.1
|
—
|
|
PANSS - Negative Subscale - Phases 1 and 2
Phase 1 - Negative Score - Change
|
-1.8 units on a scale
Standard Deviation 4.1
|
-1.0 units on a scale
Standard Deviation 2.8
|
—
|
|
PANSS - Negative Subscale - Phases 1 and 2
Phase 2 - Negative Score - Day 14
|
18.5 units on a scale
Standard Deviation 5.8
|
20.7 units on a scale
Standard Deviation 4.4
|
—
|
|
PANSS - Negative Subscale - Phases 1 and 2
Phase 2 - Negative Score - Change
|
-0.1 units on a scale
Standard Deviation 0.9
|
-0.9 units on a scale
Standard Deviation 2.9
|
—
|
SECONDARY outcome
Timeframe: Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. General Psychopathology Subscale: 16 Items, (minimum score = 16, maximum score = 112)
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
PANSS - General Psychopathology Subscale - Phases 1 and 2
Phase 1 - General Score - Baseline
|
37.6 units on a scale
Standard Deviation 6.0
|
36.4 units on a scale
Standard Deviation 5.1
|
—
|
|
PANSS - General Psychopathology Subscale - Phases 1 and 2
Phase 1 - General Score - Day 14
|
35.3 units on a scale
Standard Deviation 7.1
|
35.5 units on a scale
Standard Deviation 6.4
|
—
|
|
PANSS - General Psychopathology Subscale - Phases 1 and 2
Phase 1 - General Score - Change
|
-2.2 units on a scale
Standard Deviation 7.0
|
-0.6 units on a scale
Standard Deviation 3.9
|
—
|
|
PANSS - General Psychopathology Subscale - Phases 1 and 2
Phase 2 - General Score - Day 14
|
34.7 units on a scale
Standard Deviation 6.4
|
36.2 units on a scale
Standard Deviation 6.6
|
—
|
|
PANSS - General Psychopathology Subscale - Phases 1 and 2
Phase 2 - General Score - Day 28
|
32.4 units on a scale
Standard Deviation 5.6
|
32.4 units on a scale
Standard Deviation 5.3
|
—
|
|
PANSS - General Psychopathology Subscale - Phases 1 and 2
Phase 2 - General Score - Change
|
-2.1 units on a scale
Standard Deviation 5.2
|
-3.7 units on a scale
Standard Deviation 4.5
|
—
|
SECONDARY outcome
Timeframe: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210.
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD
Phase 1 Average Percent Change from Baseline
|
-6.7 percent change
Standard Deviation 12.8
|
-3.2 percent change
Standard Deviation 9.0
|
—
|
|
Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD
Phase 2 Average Percentage Change from Day 14
|
-3.0 percent change
Standard Deviation 10.5
|
-3.3 percent change
Standard Deviation 8.1
|
—
|
SECONDARY outcome
Timeframe: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Phase 1 analysis combines the 34 subjects assigned to Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and the 18 subjects assigned to the Drug-Drug group with complete data at all visits. Per SPCD, the Phase 2 data includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with complete data at all visits.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210.
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD
Phase 2 % of subjects with >=20% reduction
|
0 percent of subjects
|
5.56 percent of subjects
|
—
|
|
Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD
Phase 1 % of subjects with >=20% reduction
|
16.67 percent of subjects
|
0 percent of subjects
|
—
|
SECONDARY outcome
Timeframe: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Positive subscore scale: 7 items (minimum score = 7; maximum score = 49)
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD
Phase 1 Average Percent Change from Baseline
|
-7.9 percent change
Standard Deviation 8.1
|
-3.2 percent change
Standard Deviation 13.6
|
—
|
|
Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD
Phase 2 Average Percentage Change from Day 14
|
-3.5 percent change
Standard Deviation 15.4
|
-2.9 percent change
Standard Deviation 12.5
|
—
|
SECONDARY outcome
Timeframe: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Phase 1 analysis combines the 34 subjects assigned to Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and the 18 subjects assigned to the Drug-Drug group with complete data at all visits. Per SPCD, the Phase 2 data includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with complete data at all visits.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Negative subscore scale: 7 items (minimum score = 7; maximum score = 49)
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD
Phase 1 Average Percent Change from Baseline
|
-7.1 percent change
Standard Deviation 17.6
|
-4.6 percent change
Standard Deviation 14.9
|
—
|
|
Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD
Phase 2 Average Percentage Change from Day 14
|
-7.9 percent change
Standard Deviation 12.3
|
-2.1 percent change
Standard Deviation 16.5
|
—
|
SECONDARY outcome
Timeframe: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. General Psychopathology subscore scale: 16 items (minimum score = 16; maximum score = 112)
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD
Phase 1 Average Percent Change from Baseline
|
-4.8 percent change
Standard Deviation 18.3
|
-1.8 percent change
Standard Deviation 10.9
|
—
|
|
Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD
Phase 2 Average Percentage Change from Day 14
|
0.47 percent change
Standard Deviation 13.3
|
-3.7 percent change
Standard Deviation 8.7
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph1 analysis includes 34 subjects with Baseline MATRICS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 subjects the Drug-Drug group. Per SPCD, Ph 2 excludes the 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with Baseline MATRICS data.
MATRICS: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). The MATRICS Consensus Cognitive Battery is the standard tool for assessing cognitive change in trials of cognitive-enhancing agents in schizophrenia. The MCCB domains include: Speed of Processing; Attention/Vigilance; Working Memory; Verbal Learning; Visual Learning; Reasoning \& Problem-Solving; and Social Cognition and the battery takes about 80 minutes to complete. The MCCB composite score represents a global measure of cognition. MCCB composite T scores are between 40 and 60 (normal range) and \< 40 (below normal range).
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2
Phase 1 - Baseline
|
26.2 T-scores
Standard Deviation 14.3
|
26.5 T-scores
Standard Deviation 14.5
|
—
|
|
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2
Phase 1 - Day 14
|
29.3 T-scores
Standard Deviation 12.9
|
28.6 T-scores
Standard Deviation 16.2
|
—
|
|
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2
Phase 1 - Change
|
3.1 T-scores
Standard Deviation 3.9
|
1.4 T-scores
Standard Deviation 5.1
|
—
|
|
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2
Phase 2 - Day 14
|
28.8 T-scores
Standard Deviation 12.8
|
28.4 T-scores
Standard Deviation 18.8
|
—
|
|
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2
Phase 2 - Day 28
|
30.3 T-scores
Standard Deviation 13.6
|
31.0 T-scores
Standard Deviation 18.0
|
—
|
|
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2
Phase 2 - Change
|
3.3 T-scores
Standard Deviation 4.2
|
2.6 T-scores
Standard Deviation 5.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline 1 (Day -1), 7 Hours Post-Infusion 1, Baseline 2 (Day 13), 7 Hours Post-Infusion 2, Final Follow-Up, including early termination visitsPopulation: Includes all subjects with AIMS data at Phases 1 and 2
Abnormal Involuntary Movement Scale (AIMS): The AIMS Total Dyskinesia Score was calculated by averaging the first 7 items of the AIMS. The 7 items included in the AIMS Dyskinesia Score are rated on a scale from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score ranges from 0 to 4; a higher score reflects increased severity.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Average AIMS Total Scores (Items 1-7) by Group and Timepoint
Baseline 1
|
0.72 units on a scale
Standard Deviation 1.41
|
0.56 units on a scale
Standard Deviation 0.96
|
0.56 units on a scale
Standard Deviation 0.96
|
|
Average AIMS Total Scores (Items 1-7) by Group and Timepoint
7 Hours Post-Infusion 1
|
0.56 units on a scale
Standard Deviation 1.10
|
0.31 units on a scale
Standard Deviation 0.48
|
0.31 units on a scale
Standard Deviation 0.48
|
|
Average AIMS Total Scores (Items 1-7) by Group and Timepoint
Baseline 2
|
0.44 units on a scale
Standard Deviation 0.92
|
1.00 units on a scale
Standard Deviation 1.47
|
1.00 units on a scale
Standard Deviation 1.47
|
|
Average AIMS Total Scores (Items 1-7) by Group and Timepoint
7 Hours Post-Infusion 2
|
0.47 units on a scale
Standard Deviation 0.87
|
0.54 units on a scale
Standard Deviation 0.88
|
0.54 units on a scale
Standard Deviation 0.88
|
|
Average AIMS Total Scores (Items 1-7) by Group and Timepoint
Final follow-up
|
1.00 units on a scale
Standard Deviation 2.09
|
0.93 units on a scale
Standard Deviation 1.67
|
0.93 units on a scale
Standard Deviation 1.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day -1), Follow-Up = reported at any assessment thereafter, including 7 hours after Infusions #1 and #2, Baseline 2 (Day 13) and final follow-up, including early termination visits.Population: For each item, percentages of participants rated as exhibiting behaviors at the "mild" level or higher, or for items 11 and 12, as being present versus not (yes/no rated) are provided per treatment group.
Abnormal Involuntary Movement Scale (AIMS): The AIMS is a 12-item anchored score that is clinician administered and scored. Items are scored on a 0 (none) to 4 (severe) basis; items 8-10 deal with global severity; items 11-12 are yes-no questions concerning problems with teeth and/or dentures.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Follow-Up - Incapacitation (Item 9)
|
0.0 percentage of participants
|
6.3 percentage of participants
|
0.0 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Baseline - Overall Severity Index (Item 8)
|
5.6 percentage of participants
|
6.3 percentage of participants
|
11.1 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Follow-Up - Overall Severity Index (Item 8)
|
16.7 percentage of participants
|
18.8 percentage of participants
|
16.7 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Baseline - Incapacitation (Item 9)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.6 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Baseline - Awareness (Item 10)
|
11.1 percentage of participants
|
6.3 percentage of participants
|
5.6 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Follow-Up - Awareness (Item 10)
|
5.6 percentage of participants
|
18.8 percentage of participants
|
5.6 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Baseline - Dental Problem (Item 11; % yes)
|
22.2 percentage of participants
|
31.3 percentage of participants
|
16.7 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Follow-Up - Dental Problem (Item 11; % yes)
|
27.8 percentage of participants
|
37.5 percentage of participants
|
22.2 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Baseline - Dentures (Item 12; % yes)
|
5.6 percentage of participants
|
18.8 percentage of participants
|
16.7 percentage of participants
|
|
Percent of Participants Rated as ≥ "Mild" or as "Yes" on AIMS Items 8-12
Follow-Up - Dentures (Item 12; % yes)
|
11.1 percentage of participants
|
31.3 percentage of participants
|
22.2 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28Population: Ph1 analysis includes 34 subjects with Baseline UPSA-B data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 subjects the Drug-Drug group. Per SPCD, Ph 2 excludes the 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with Baseline UPSA-B data.
The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) consists of two of the five original UPSA domains, finances and communication. Each subscale contributes 50 points; total scores range from 0 to 100 points with higher scores reflecting better performance.
Outcome measures
| Measure |
Drug
n=32 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=34 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2
Phase 2 - Change
|
5.5 units on a scale
Standard Deviation 7.7
|
-1.5 units on a scale
Standard Deviation 10.9
|
—
|
|
Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2
Phase 1 - Baseline
|
74.0 units on a scale
Standard Deviation 17.2
|
71.8 units on a scale
Standard Deviation 17.1
|
—
|
|
Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2
Phase 1 - Day 14
|
76.7 units on a scale
Standard Deviation 17.4
|
77.9 units on a scale
Standard Deviation 14.6
|
—
|
|
Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2
Phase 1 - Change
|
2.7 units on a scale
Standard Deviation 7.6
|
6.2 units on a scale
Standard Deviation 9.9
|
—
|
|
Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2
Phase 2 - Day 14
|
80.2 units on a scale
Standard Deviation 13.1
|
76.0 units on a scale
Standard Deviation 15.9
|
—
|
|
Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2
Phase 2 - Day 28
|
85.4 units on a scale
Standard Deviation 11.2
|
74.5 units on a scale
Standard Deviation 20.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening Visit, Days 3 (Baseline 1), Days 7, 13 (Baseline 2), 21 and 28Population: All subjects with C-SSRS data reporting suicidal ideation/behavior
The Columbia Suicide Severity Rating Scale (C-SSRS): The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed in the National Institute of Mental Health Treatment of Adolescent Suicide Attempters Study to assess severity and track suicidal events through any treatment. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS can also be used during treatment to monitor for clinical worsening or improvement. It contains 5 rating scale questions (yes/no) for suicidal ideation increasing severity and 5 rating scale questions (yes/no) for suicidal behavior of increasing severity. The time frame is for both lifetime and the past six months for the Baseline/Screening scale and since the last visit for the Since Last Visit scale.
Outcome measures
| Measure |
Drug
n=23 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=19 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation (SI) (% any of the following)
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Wish to be dead
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Non-specific active suicidal thoughts
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Active SI w/any method (no plan) W/O intent to act
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Active SI w/some intent to act, W/O specific plan
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Active SI with specific plan & intent
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal behavior (% any of the following)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Prepatory acts or behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Aborted attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Interrupted attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Non-fatal suicide attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
Self-injurious behavior W/O suicidal intent
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hoursPopulation: Includes all subjects during Phase 1 (i.e., infusion 1)
Infusion 1 (Day 0) - Systolic Blood Pressure at all time points by group "Phase" in this analysis refers to the infusion stage as defined in the protocol.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min015
|
111.28 mmHg
Standard Deviation 9.48
|
125.75 mmHg
Standard Deviation 10.51
|
121.94 mmHg
Standard Deviation 11.58
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min020
|
108.28 mmHg
Standard Deviation 10.21
|
124.63 mmHg
Standard Deviation 9.94
|
121.11 mmHg
Standard Deviation 10.81
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 1 - min000s1
|
121.79 mmHg
Standard Deviation 14.46
|
121.50 mmHg
Standard Deviation 10.65
|
123.78 mmHg
Standard Deviation 11.46
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 1 - min005s1
|
116.95 mmHg
Standard Deviation 12.78
|
126.13 mmHg
Standard Deviation 13.01
|
121.94 mmHg
Standard Deviation 14.39
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min000
|
114.89 mmHg
Standard Deviation 13.13
|
125.13 mmHg
Standard Deviation 11.04
|
121.00 mmHg
Standard Deviation 12.86
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min005
|
111.32 mmHg
Standard Deviation 11.51
|
124.38 mmHg
Standard Deviation 10.29
|
121.00 mmHg
Standard Deviation 14.12
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min010
|
112.72 mmHg
Standard Deviation 12.84
|
127.06 mmHg
Standard Deviation 8.93
|
122.33 mmHg
Standard Deviation 11.56
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min025
|
109.83 mmHg
Standard Deviation 10.70
|
126.63 mmHg
Standard Deviation 11.89
|
121.11 mmHg
Standard Deviation 11.80
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min030
|
108.61 mmHg
Standard Deviation 10.01
|
125.13 mmHg
Standard Deviation 9.84
|
119.67 mmHg
Standard Deviation 13.77
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min040
|
111.82 mmHg
Standard Deviation 9.80
|
125.63 mmHg
Standard Deviation 11.86
|
122.56 mmHg
Standard Deviation 11.46
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min050
|
111.00 mmHg
Standard Deviation 8.89
|
125.73 mmHg
Standard Deviation 9.32
|
122.56 mmHg
Standard Deviation 11.46
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min060
|
112.53 mmHg
Standard Deviation 11.99
|
126.87 mmHg
Standard Deviation 9.69
|
120.17 mmHg
Standard Deviation 12.91
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min070
|
114.82 mmHg
Standard Deviation 12.83
|
126.27 mmHg
Standard Deviation 8.86
|
120.11 mmHg
Standard Deviation 10.76
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min080
|
110.00 mmHg
Standard Deviation 9.98
|
125.53 mmHg
Standard Deviation 9.62
|
120.83 mmHg
Standard Deviation 13.90
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min090
|
111.94 mmHg
Standard Deviation 9.83
|
125.00 mmHg
Standard Deviation 11.14
|
121.33 mmHg
Standard Deviation 12.88
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min100
|
111.00 mmHg
Standard Deviation 12.97
|
123.87 mmHg
Standard Deviation 11.75
|
122.11 mmHg
Standard Deviation 12.39
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min110
|
112.29 mmHg
Standard Deviation 7.83
|
128.33 mmHg
Standard Deviation 10.60
|
122.83 mmHg
Standard Deviation 12.32
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min120
|
111.76 mmHg
Standard Deviation 10.56
|
124.93 mmHg
Standard Deviation 12.57
|
119.06 mmHg
Standard Deviation 15.30
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min130
|
109.82 mmHg
Standard Deviation 9.19
|
125.20 mmHg
Standard Deviation 8.99
|
119.17 mmHg
Standard Deviation 10.63
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min140
|
109.47 mmHg
Standard Deviation 7.34
|
127.67 mmHg
Standard Deviation 9.76
|
119.72 mmHg
Standard Deviation 11.20
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min150
|
110.12 mmHg
Standard Deviation 9.62
|
126.93 mmHg
Standard Deviation 10.75
|
123.39 mmHg
Standard Deviation 12.95
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min160
|
107.88 mmHg
Standard Deviation 9.97
|
126.00 mmHg
Standard Deviation 9.56
|
121.72 mmHg
Standard Deviation 15.23
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min170
|
109.35 mmHg
Standard Deviation 11.89
|
124.33 mmHg
Standard Deviation 9.51
|
122.72 mmHg
Standard Deviation 15.14
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min180
|
110.06 mmHg
Standard Deviation 9.85
|
127.07 mmHg
Standard Deviation 12.63
|
123.22 mmHg
Standard Deviation 13.01
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min190
|
110.12 mmHg
Standard Deviation 11.60
|
125.13 mmHg
Standard Deviation 13.10
|
121.94 mmHg
Standard Deviation 12.46
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min200
|
107.41 mmHg
Standard Deviation 12.57
|
125.40 mmHg
Standard Deviation 13.00
|
122.67 mmHg
Standard Deviation 14.63
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min210
|
109.71 mmHg
Standard Deviation 8.08
|
131.87 mmHg
Standard Deviation 13.79
|
122.94 mmHg
Standard Deviation 11.34
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min220
|
109.82 mmHg
Standard Deviation 9.57
|
125.73 mmHg
Standard Deviation 13.24
|
125.89 mmHg
Standard Deviation 14.58
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min230
|
109.35 mmHg
Standard Deviation 9.57
|
126.00 mmHg
Standard Deviation 13.80
|
124.61 mmHg
Standard Deviation 13.75
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min240
|
109.53 mmHg
Standard Deviation 9.13
|
128.67 mmHg
Standard Deviation 14.01
|
124.44 mmHg
Standard Deviation 14.16
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min000
|
107.50 mmHg
Standard Deviation 11.53
|
128.38 mmHg
Standard Deviation 13.87
|
125.22 mmHg
Standard Deviation 13.80
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min005
|
114.44 mmHg
Standard Deviation 11.01
|
126.13 mmHg
Standard Deviation 13.84
|
123.12 mmHg
Standard Deviation 10.01
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min010
|
116.28 mmHg
Standard Deviation 11.74
|
127.33 mmHg
Standard Deviation 12.80
|
122.06 mmHg
Standard Deviation 11.62
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min015
|
117.22 mmHg
Standard Deviation 11.07
|
128.40 mmHg
Standard Deviation 16.79
|
124.67 mmHg
Standard Deviation 11.96
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min020
|
117.39 mmHg
Standard Deviation 9.12
|
128.80 mmHg
Standard Deviation 13.04
|
124.50 mmHg
Standard Deviation 12.08
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min025
|
116.33 mmHg
Standard Deviation 12.58
|
129.53 mmHg
Standard Deviation 14.94
|
126.72 mmHg
Standard Deviation 14.74
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min030
|
118.56 mmHg
Standard Deviation 11.93
|
129.81 mmHg
Standard Deviation 13.96
|
124.00 mmHg
Standard Deviation 14.12
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min040
|
119.67 mmHg
Standard Deviation 12.03
|
128.33 mmHg
Standard Deviation 14.99
|
123.33 mmHg
Standard Deviation 14.48
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min050
|
117.33 mmHg
Standard Deviation 13.91
|
128.47 mmHg
Standard Deviation 11.86
|
123.11 mmHg
Standard Deviation 13.78
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min060
|
122.22 mmHg
Standard Deviation 12.35
|
129.93 mmHg
Standard Deviation 12.21
|
124.61 mmHg
Standard Deviation 14.97
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min070
|
122.33 mmHg
Standard Deviation 13.78
|
130.27 mmHg
Standard Deviation 11.51
|
122.72 mmHg
Standard Deviation 15.86
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min080
|
118.83 mmHg
Standard Deviation 12.78
|
128.47 mmHg
Standard Deviation 11.86
|
122.94 mmHg
Standard Deviation 14.49
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min090
|
117.67 mmHg
Standard Deviation 12.56
|
129.20 mmHg
Standard Deviation 13.03
|
124.06 mmHg
Standard Deviation 10.94
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min100
|
120.44 mmHg
Standard Deviation 11.87
|
125.67 mmHg
Standard Deviation 11.63
|
121.72 mmHg
Standard Deviation 10.65
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min110
|
122.61 mmHg
Standard Deviation 13.42
|
129.27 mmHg
Standard Deviation 11.49
|
125.06 mmHg
Standard Deviation 14.58
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min120
|
122.22 mmHg
Standard Deviation 13.41
|
128.67 mmHg
Standard Deviation 10.99
|
124.44 mmHg
Standard Deviation 12.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hoursPopulation: Includes all subjects during Phase 1 (i.e., infusion 1)
Infusion 1 (Day 0) - Diastolic Blood Pressure at all time points by group "Phase" in this analysis refers to the infusion stage as defined in the protocol.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 1 - min000s1
|
71.63 mmHg
Standard Deviation 19.03
|
75.13 mmHg
Standard Deviation 10.44
|
75.11 mmHg
Standard Deviation 10.12
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 1 - min005s1
|
68.79 mmHg
Standard Deviation 10.12
|
75.38 mmHg
Standard Deviation 6.30
|
74.94 mmHg
Standard Deviation 9.91
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min000
|
67.58 mmHg
Standard Deviation 10.18
|
74.44 mmHg
Standard Deviation 7.28
|
74.72 mmHg
Standard Deviation 11.88
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min005
|
66.37 mmHg
Standard Deviation 12.88
|
74.31 mmHg
Standard Deviation 7.01
|
74.39 mmHg
Standard Deviation 8.42
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min010
|
65.72 mmHg
Standard Deviation 14.70
|
75.50 mmHg
Standard Deviation 8.09
|
73.72 mmHg
Standard Deviation 9.50
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min015
|
62.67 mmHg
Standard Deviation 9.94
|
74.75 mmHg
Standard Deviation 8.38
|
72.78 mmHg
Standard Deviation 8.61
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min020
|
62.06 mmHg
Standard Deviation 9.33
|
75.19 mmHg
Standard Deviation 8.29
|
74.33 mmHg
Standard Deviation 12.25
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min025
|
62.33 mmHg
Standard Deviation 8.61
|
74.31 mmHg
Standard Deviation 6.02
|
72.83 mmHg
Standard Deviation 11.20
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min030
|
60.78 mmHg
Standard Deviation 8.93
|
75.50 mmHg
Standard Deviation 8.09
|
72.06 mmHg
Standard Deviation 11.67
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min040
|
61.29 mmHg
Standard Deviation 7.46
|
75.06 mmHg
Standard Deviation 9.76
|
72.67 mmHg
Standard Deviation 11.66
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min050
|
60.65 mmHg
Standard Deviation 7.52
|
76.47 mmHg
Standard Deviation 10.23
|
71.28 mmHg
Standard Deviation 10.06
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min060
|
61.88 mmHg
Standard Deviation 9.50
|
75.80 mmHg
Standard Deviation 9.30
|
71.94 mmHg
Standard Deviation 11.11
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min070
|
64.53 mmHg
Standard Deviation 11.21
|
75.27 mmHg
Standard Deviation 9.62
|
71.11 mmHg
Standard Deviation 12.74
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min080
|
62.41 mmHg
Standard Deviation 10.89
|
76.73 mmHg
Standard Deviation 9.80
|
71.61 mmHg
Standard Deviation 11.69
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min090
|
64.18 mmHg
Standard Deviation 11.48
|
74.53 mmHg
Standard Deviation 9.81
|
73.11 mmHg
Standard Deviation 14.06
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min100
|
62.29 mmHg
Standard Deviation 8.96
|
74.87 mmHg
Standard Deviation 7.74
|
73.94 mmHg
Standard Deviation 11.50
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min110
|
63.94 mmHg
Standard Deviation 6.97
|
77.07 mmHg
Standard Deviation 12.02
|
72.06 mmHg
Standard Deviation 12.98
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min120
|
66.94 mmHg
Standard Deviation 12.02
|
74.20 mmHg
Standard Deviation 8.94
|
72.28 mmHg
Standard Deviation 14.71
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min130
|
62.47 mmHg
Standard Deviation 8.87
|
76.27 mmHg
Standard Deviation 8.44
|
69.72 mmHg
Standard Deviation 13.47
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min140
|
61.94 mmHg
Standard Deviation 8.75
|
78.27 mmHg
Standard Deviation 8.96
|
71.06 mmHg
Standard Deviation 10.98
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min150
|
64.53 mmHg
Standard Deviation 6.38
|
75.60 mmHg
Standard Deviation 8.10
|
73.83 mmHg
Standard Deviation 11.74
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min160
|
61.88 mmHg
Standard Deviation 8.99
|
75.53 mmHg
Standard Deviation 17.01
|
72.22 mmHg
Standard Deviation 10.50
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min170
|
62.29 mmHg
Standard Deviation 6.28
|
74.40 mmHg
Standard Deviation 9.30
|
72.83 mmHg
Standard Deviation 11.74
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min180
|
62.06 mmHg
Standard Deviation 9.05
|
74.20 mmHg
Standard Deviation 9.67
|
72.22 mmHg
Standard Deviation 12.74
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min190
|
63.47 mmHg
Standard Deviation 9.41
|
74.67 mmHg
Standard Deviation 7.48
|
73.56 mmHg
Standard Deviation 11.93
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min200
|
64.18 mmHg
Standard Deviation 7.57
|
78.60 mmHg
Standard Deviation 9.83
|
74.33 mmHg
Standard Deviation 11.63
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min210
|
63.82 mmHg
Standard Deviation 9.51
|
76.20 mmHg
Standard Deviation 8.83
|
75.56 mmHg
Standard Deviation 11.22
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min220
|
63.47 mmHg
Standard Deviation 10.40
|
76.00 mmHg
Standard Deviation 9.06
|
75.17 mmHg
Standard Deviation 12.94
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min230
|
60.82 mmHg
Standard Deviation 9.13
|
76.40 mmHg
Standard Deviation 7.95
|
74.17 mmHg
Standard Deviation 9.82
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min240
|
63.47 mmHg
Standard Deviation 8.46
|
76.53 mmHg
Standard Deviation 7.79
|
74.00 mmHg
Standard Deviation 10.19
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min000
|
62.56 mmHg
Standard Deviation 8.69
|
77.50 mmHg
Standard Deviation 8.40
|
74.67 mmHg
Standard Deviation 11.11
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min005
|
67.17 mmHg
Standard Deviation 9.67
|
76.40 mmHg
Standard Deviation 8.49
|
76.18 mmHg
Standard Deviation 9.19
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min010
|
66.78 mmHg
Standard Deviation 9.90
|
78.07 mmHg
Standard Deviation 9.03
|
75.56 mmHg
Standard Deviation 13.17
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min015
|
69.00 mmHg
Standard Deviation 10.84
|
76.20 mmHg
Standard Deviation 9.65
|
75.78 mmHg
Standard Deviation 11.33
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min020
|
71.72 mmHg
Standard Deviation 11.10
|
77.80 mmHg
Standard Deviation 12.25
|
75.61 mmHg
Standard Deviation 12.53
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min025
|
66.72 mmHg
Standard Deviation 11.40
|
78.87 mmHg
Standard Deviation 10.80
|
77.06 mmHg
Standard Deviation 10.80
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min030
|
69.67 mmHg
Standard Deviation 9.00
|
78.81 mmHg
Standard Deviation 9.70
|
75.33 mmHg
Standard Deviation 11.75
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min040
|
68.06 mmHg
Standard Deviation 11.43
|
77.53 mmHg
Standard Deviation 10.85
|
75.89 mmHg
Standard Deviation 11.84
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min050
|
69.56 mmHg
Standard Deviation 10.78
|
78.40 mmHg
Standard Deviation 7.27
|
75.17 mmHg
Standard Deviation 11.81
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min060
|
68.83 mmHg
Standard Deviation 10.44
|
79.33 mmHg
Standard Deviation 11.17
|
74.61 mmHg
Standard Deviation 10.87
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min070
|
70.22 mmHg
Standard Deviation 10.33
|
78.13 mmHg
Standard Deviation 7.49
|
75.28 mmHg
Standard Deviation 9.37
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min080
|
71.89 mmHg
Standard Deviation 10.02
|
76.60 mmHg
Standard Deviation 7.49
|
75.06 mmHg
Standard Deviation 13.17
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min090
|
69.89 mmHg
Standard Deviation 7.08
|
79.07 mmHg
Standard Deviation 9.06
|
74.44 mmHg
Standard Deviation 10.07
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min100
|
69.50 mmHg
Standard Deviation 9.24
|
76.80 mmHg
Standard Deviation 10.75
|
73.56 mmHg
Standard Deviation 10.61
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min110
|
71.61 mmHg
Standard Deviation 8.13
|
76.53 mmHg
Standard Deviation 10.64
|
74.22 mmHg
Standard Deviation 9.74
|
|
Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min120
|
70.61 mmHg
Standard Deviation 9.86
|
78.27 mmHg
Standard Deviation 8.40
|
75.89 mmHg
Standard Deviation 8.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hoursPopulation: Includes all subjects during Phase 2 (i.e., infusion 2)
Infusion 2 (Day 14) - Systolic Blood Pressure at all time points by group "Phase" in this analysis refers to the infusion stage as defined in the protocol.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=14 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 1 - min000s1
|
120.69 mmHg
Standard Deviation 11.84
|
121.92 mmHg
Standard Deviation 9.66
|
122.61 mmHg
Standard Deviation 10.22
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 1 - min005s1
|
112.69 mmHg
Standard Deviation 12.38
|
120.77 mmHg
Standard Deviation 12.38
|
119.39 mmHg
Standard Deviation 10.67
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min000
|
110.88 mmHg
Standard Deviation 11.61
|
120.92 mmHg
Standard Deviation 14.20
|
120.78 mmHg
Standard Deviation 12.08
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min005
|
107.50 mmHg
Standard Deviation 11.36
|
116.31 mmHg
Standard Deviation 9.96
|
120.39 mmHg
Standard Deviation 12.22
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min010
|
108.50 mmHg
Standard Deviation 9.39
|
113.38 mmHg
Standard Deviation 12.53
|
120.41 mmHg
Standard Deviation 12.62
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min015
|
108.88 mmHg
Standard Deviation 9.06
|
113.46 mmHg
Standard Deviation 10.32
|
117.28 mmHg
Standard Deviation 13.35
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min020
|
108.19 mmHg
Standard Deviation 8.93
|
112.62 mmHg
Standard Deviation 10.66
|
117.94 mmHg
Standard Deviation 12.65
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min025
|
110.81 mmHg
Standard Deviation 11.11
|
115.62 mmHg
Standard Deviation 13.88
|
118.22 mmHg
Standard Deviation 14.40
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min030
|
109.88 mmHg
Standard Deviation 8.43
|
113.69 mmHg
Standard Deviation 16.09
|
116.44 mmHg
Standard Deviation 13.40
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min040
|
108.06 mmHg
Standard Deviation 8.46
|
117.54 mmHg
Standard Deviation 16.58
|
118.94 mmHg
Standard Deviation 11.57
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min050
|
109.00 mmHg
Standard Deviation 10.22
|
112.77 mmHg
Standard Deviation 13.91
|
118.56 mmHg
Standard Deviation 15.60
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min060
|
109.63 mmHg
Standard Deviation 13.20
|
113.31 mmHg
Standard Deviation 14.12
|
116.94 mmHg
Standard Deviation 12.75
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min070
|
108.56 mmHg
Standard Deviation 10.46
|
113.15 mmHg
Standard Deviation 12.15
|
118.50 mmHg
Standard Deviation 14.20
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min080
|
108.50 mmHg
Standard Deviation 10.98
|
113.08 mmHg
Standard Deviation 15.34
|
118.50 mmHg
Standard Deviation 13.57
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min090
|
109.06 mmHg
Standard Deviation 10.59
|
109.00 mmHg
Standard Deviation 11.63
|
118.06 mmHg
Standard Deviation 12.49
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min100
|
106.94 mmHg
Standard Deviation 11.58
|
111.50 mmHg
Standard Deviation 16.10
|
119.00 mmHg
Standard Deviation 14.98
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min110
|
105.67 mmHg
Standard Deviation 7.80
|
112.46 mmHg
Standard Deviation 16.04
|
120.39 mmHg
Standard Deviation 11.95
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min120
|
105.87 mmHg
Standard Deviation 9.19
|
106.33 mmHg
Standard Deviation 10.87
|
118.83 mmHg
Standard Deviation 15.25
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min130
|
108.53 mmHg
Standard Deviation 10.70
|
110.17 mmHg
Standard Deviation 11.75
|
120.06 mmHg
Standard Deviation 13.58
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min140
|
111.27 mmHg
Standard Deviation 10.50
|
110.54 mmHg
Standard Deviation 11.23
|
120.33 mmHg
Standard Deviation 15.11
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min150
|
112.13 mmHg
Standard Deviation 11.42
|
110.83 mmHg
Standard Deviation 18.52
|
117.67 mmHg
Standard Deviation 12.76
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min160
|
109.87 mmHg
Standard Deviation 11.11
|
116.17 mmHg
Standard Deviation 13.07
|
121.17 mmHg
Standard Deviation 13.79
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min170
|
114.33 mmHg
Standard Deviation 12.61
|
113.33 mmHg
Standard Deviation 12.04
|
120.61 mmHg
Standard Deviation 12.65
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min180
|
111.27 mmHg
Standard Deviation 9.38
|
113.92 mmHg
Standard Deviation 11.77
|
117.67 mmHg
Standard Deviation 11.44
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min190
|
110.47 mmHg
Standard Deviation 9.82
|
114.83 mmHg
Standard Deviation 16.46
|
120.72 mmHg
Standard Deviation 11.74
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min200
|
110.40 mmHg
Standard Deviation 13.47
|
115.08 mmHg
Standard Deviation 16.76
|
120.94 mmHg
Standard Deviation 14.24
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min210
|
113.13 mmHg
Standard Deviation 14.71
|
114.33 mmHg
Standard Deviation 17.85
|
121.17 mmHg
Standard Deviation 11.75
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min220
|
109.20 mmHg
Standard Deviation 15.18
|
112.33 mmHg
Standard Deviation 11.54
|
120.06 mmHg
Standard Deviation 11.44
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min230
|
110.27 mmHg
Standard Deviation 12.79
|
113.58 mmHg
Standard Deviation 12.92
|
118.83 mmHg
Standard Deviation 12.64
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min240
|
108.53 mmHg
Standard Deviation 9.48
|
111.83 mmHg
Standard Deviation 12.58
|
119.00 mmHg
Standard Deviation 12.29
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min000
|
107.75 mmHg
Standard Deviation 9.94
|
113.25 mmHg
Standard Deviation 13.51
|
118.22 mmHg
Standard Deviation 120.28
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min005
|
111.06 mmHg
Standard Deviation 12.41
|
118.25 mmHg
Standard Deviation 18.23
|
120.28 mmHg
Standard Deviation 11.93
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min010
|
116.88 mmHg
Standard Deviation 16.70
|
122.83 mmHg
Standard Deviation 16.03
|
122.94 mmHg
Standard Deviation 10.91
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min015
|
114.75 mmHg
Standard Deviation 15.07
|
124.58 mmHg
Standard Deviation 16.14
|
122.78 mmHg
Standard Deviation 11.70
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min020
|
115.00 mmHg
Standard Deviation 11.55
|
122.92 mmHg
Standard Deviation 13.24
|
121.56 mmHg
Standard Deviation 12.60
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min025
|
116.00 mmHg
Standard Deviation 12.41
|
125.83 mmHg
Standard Deviation 16.94
|
126.67 mmHg
Standard Deviation 15.06
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min030
|
117.50 mmHg
Standard Deviation 12.56
|
123.67 mmHg
Standard Deviation 16.54
|
126.06 mmHg
Standard Deviation 14.86
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min040
|
118.44 mmHg
Standard Deviation 11.40
|
123.92 mmHg
Standard Deviation 11.24
|
122.11 mmHg
Standard Deviation 13.75
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min050
|
122.75 mmHg
Standard Deviation 22.66
|
124.17 mmHg
Standard Deviation 13.19
|
122.72 mmHg
Standard Deviation 14.82
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min060
|
125.31 mmHg
Standard Deviation 14.93
|
121.08 mmHg
Standard Deviation 12.45
|
123.17 mmHg
Standard Deviation 15.00
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min070
|
122.44 mmHg
Standard Deviation 19.68
|
120.33 mmHg
Standard Deviation 10.46
|
124.78 mmHg
Standard Deviation 14.82
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min080
|
122.38 mmHg
Standard Deviation 15.21
|
121.83 mmHg
Standard Deviation 14.65
|
123.17 mmHg
Standard Deviation 13.34
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min090
|
122.25 mmHg
Standard Deviation 14.19
|
125.08 mmHg
Standard Deviation 13.73
|
126.28 mmHg
Standard Deviation 14.52
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min100
|
121.94 mmHg
Standard Deviation 21.68
|
123.92 mmHg
Standard Deviation 10.99
|
122.94 mmHg
Standard Deviation 16.25
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min110
|
123.50 mmHg
Standard Deviation 13.57
|
125.17 mmHg
Standard Deviation 16.51
|
125.06 mmHg
Standard Deviation 11.88
|
|
Systolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min120
|
122.31 mmHg
Standard Deviation 16.41
|
125.75 mmHg
Standard Deviation 12.26
|
125.00 mmHg
Standard Deviation 12.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hoursPopulation: Includes all subjects during Phase 1 (i.e., infusion 1)
Infusion 2 (Day 14) - Diastolic Blood Pressure at all time points by group
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=14 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min050
|
60.25 mmHg
Standard Deviation 8.42
|
71.89 mmHg
Standard Deviation 12.07
|
71.89 mmHg
Standard Deviation 12.07
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min060
|
60.38 mmHg
Standard Deviation 11.97
|
71.44 mmHg
Standard Deviation 12.23
|
71.44 mmHg
Standard Deviation 12.23
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min070
|
59.19 mmHg
Standard Deviation 10.78
|
71.00 mmHg
Standard Deviation 10.77
|
71.00 mmHg
Standard Deviation 10.77
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min080
|
59.00 mmHg
Standard Deviation 7.38
|
70.72 mmHg
Standard Deviation 12.81
|
70.72 mmHg
Standard Deviation 12.81
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min090
|
57.13 mmHg
Standard Deviation 7.83
|
70.22 mmHg
Standard Deviation 12.34
|
70.22 mmHg
Standard Deviation 12.34
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min100
|
58.13 mmHg
Standard Deviation 8.37
|
71.00 mmHg
Standard Deviation 12.39
|
71.00 mmHg
Standard Deviation 12.39
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min110
|
59.73 mmHg
Standard Deviation 5.97
|
71.89 mmHg
Standard Deviation 11.54
|
71.89 mmHg
Standard Deviation 11.54
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min120
|
59.47 mmHg
Standard Deviation 8.59
|
68.28 mmHg
Standard Deviation 10.65
|
68.28 mmHg
Standard Deviation 10.65
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min030
|
68.81 mmHg
Standard Deviation 12.45
|
76.89 mmHg
Standard Deviation 14.57
|
76.89 mmHg
Standard Deviation 14.57
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min040
|
70.31 mmHg
Standard Deviation 14.89
|
72.39 mmHg
Standard Deviation 11.32
|
72.39 mmHg
Standard Deviation 11.32
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min130
|
60.33 mmHg
Standard Deviation 8.16
|
73.44 mmHg
Standard Deviation 11.94
|
73.44 mmHg
Standard Deviation 11.94
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min140
|
58.73 mmHg
Standard Deviation 10.23
|
71.56 mmHg
Standard Deviation 10.87
|
71.56 mmHg
Standard Deviation 10.87
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min150
|
61.87 mmHg
Standard Deviation 10.10
|
74.06 mmHg
Standard Deviation 12.80
|
74.06 mmHg
Standard Deviation 12.80
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min160
|
60.53 mmHg
Standard Deviation 7.68
|
73.94 mmHg
Standard Deviation 10.41
|
73.94 mmHg
Standard Deviation 10.41
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min170
|
61.87 mmHg
Standard Deviation 11.60
|
74.61 mmHg
Standard Deviation 8.43
|
74.61 mmHg
Standard Deviation 8.43
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min180
|
60.27 mmHg
Standard Deviation 9.00
|
72.28 mmHg
Standard Deviation 8.17
|
72.28 mmHg
Standard Deviation 8.17
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min190
|
59.73 mmHg
Standard Deviation 10.23
|
73.00 mmHg
Standard Deviation 10.99
|
73.00 mmHg
Standard Deviation 10.99
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min200
|
58.40 mmHg
Standard Deviation 7.03
|
73.56 mmHg
Standard Deviation 10.35
|
73.56 mmHg
Standard Deviation 10.35
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min210
|
60.27 mmHg
Standard Deviation 9.00
|
74.11 mmHg
Standard Deviation 11.53
|
74.11 mmHg
Standard Deviation 11.53
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min220
|
59.13 mmHg
Standard Deviation 8.60
|
72.22 mmHg
Standard Deviation 9.62
|
72.22 mmHg
Standard Deviation 9.62
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min230
|
62.00 mmHg
Standard Deviation 8.12
|
72.33 mmHg
Standard Deviation 10.48
|
72.33 mmHg
Standard Deviation 10.48
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min240
|
59.60 mmHg
Standard Deviation 8.58
|
70.11 mmHg
Standard Deviation 8.05
|
70.11 mmHg
Standard Deviation 8.05
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min000
|
59.81 mmHg
Standard Deviation 8.42
|
70.39 mmHg
Standard Deviation 8.10
|
70.39 mmHg
Standard Deviation 8.10
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min005
|
63.31 mmHg
Standard Deviation 7.87
|
71.94 mmHg
Standard Deviation 9.14
|
71.94 mmHg
Standard Deviation 9.14
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min010
|
67.06 mmHg
Standard Deviation 9.26
|
73.39 mmHg
Standard Deviation 9.76
|
73.39 mmHg
Standard Deviation 9.76
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min015
|
65.13 mmHg
Standard Deviation 10.20
|
75.67 mmHg
Standard Deviation 10.79
|
75.67 mmHg
Standard Deviation 10.79
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min020
|
69.44 mmHg
Standard Deviation 12.44
|
74.89 mmHg
Standard Deviation 9.62
|
74.89 mmHg
Standard Deviation 8.66
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min025
|
66.88 mmHg
Standard Deviation 12.94
|
76.89 mmHg
Standard Deviation 8.66
|
76.89 mmHg
Standard Deviation 8.66
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 1 - min000s1
|
69.38 mmHg
Standard Deviation 7.80
|
74.50 mmHg
Standard Deviation 8.89
|
74.50 mmHg
Standard Deviation 8.89
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 1 - min005s1
|
63.56 mmHg
Standard Deviation 8.78
|
73.89 mmHg
Standard Deviation 8.70
|
73.89 mmHg
Standard Deviation 8.70
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min000
|
63.94 mmHg
Standard Deviation 8.46
|
72.72 mmHg
Standard Deviation 8.84
|
72.72 mmHg
Standard Deviation 8.84
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min005
|
61.00 mmHg
Standard Deviation 6.23
|
71.28 mmHg
Standard Deviation 7.28
|
71.28 mmHg
Standard Deviation 7.28
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min010
|
61.63 mmHg
Standard Deviation 7.57
|
74.65 mmHg
Standard Deviation 9.03
|
74.65 mmHg
Standard Deviation 9.03
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min015
|
61.44 mmHg
Standard Deviation 9.06
|
73.50 mmHg
Standard Deviation 7.15
|
73.50 mmHg
Standard Deviation 7.15
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min020
|
63.19 mmHg
Standard Deviation 8.72
|
70.94 mmHg
Standard Deviation 7.07
|
70.94 mmHg
Standard Deviation 7.07
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min025
|
59.25 mmHg
Standard Deviation 8.29
|
71.56 mmHg
Standard Deviation 9.10
|
71.56 mmHg
Standard Deviation 9.10
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min030
|
61.75 mmHg
Standard Deviation 7.87
|
71.11 mmHg
Standard Deviation 7.23
|
71.11 mmHg
Standard Deviation 7.23
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Phase 2 - min040
|
59.94 mmHg
Standard Deviation 8.82
|
73.17 mmHg
Standard Deviation 9.07
|
73.17 mmHg
Standard Deviation 9.07
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min050
|
70.25 mmHg
Standard Deviation 10.79
|
74.72 mmHg
Standard Deviation 12.56
|
74.72 mmHg
Standard Deviation 12.56
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min060
|
67.69 mmHg
Standard Deviation 7.88
|
74.11 mmHg
Standard Deviation 11.90
|
74.11 mmHg
Standard Deviation 11.90
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min070
|
68.81 mmHg
Standard Deviation 9.72
|
76.78 mmHg
Standard Deviation 10.28
|
76.78 mmHg
Standard Deviation 10.28
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min080
|
68.88 mmHg
Standard Deviation 7.87
|
74.61 mmHg
Standard Deviation 11.25
|
74.61 mmHg
Standard Deviation 11.25
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min090
|
69.88 mmHg
Standard Deviation 8.87
|
73.83 mmHg
Standard Deviation 11.40
|
73.83 mmHg
Standard Deviation 11.40
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min100
|
69.38 mmHg
Standard Deviation 8.61
|
74.28 mmHg
Standard Deviation 12.15
|
74.28 mmHg
Standard Deviation 12.15
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min110
|
70.81 mmHg
Standard Deviation 9.09
|
77.11 mmHg
Standard Deviation 10.78
|
77.11 mmHg
Standard Deviation 10.78
|
|
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Post Infusion - min120
|
70.56 mmHg
Standard Deviation 7.69
|
78.00 mmHg
Standard Deviation 9.15
|
78.00 mmHg
Standard Deviation 9.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hoursPopulation: Includes all subjects during Phase 1 (i.e., infusion 1)
Infusion 1 (Day 0) - Heart rate at all time points by group "Phase" in this analysis refers to the infusion stage as defined in the protocol.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min005
|
85.47 bpm
Standard Deviation 13.49
|
77.88 bpm
Standard Deviation 15.13
|
78.00 bpm
Standard Deviation 17.19
|
|
Heart Rate Per Infusion Phase by Group
Phase 1 - min000s1
|
78.47 bpm
Standard Deviation 13.11
|
79.00 bpm
Standard Deviation 15.84
|
79.94 bpm
Standard Deviation 17.67
|
|
Heart Rate Per Infusion Phase by Group
Phase 1 - min005s1
|
81.21 bpm
Standard Deviation 15.79
|
77.81 bpm
Standard Deviation 14.39
|
79.44 bpm
Standard Deviation 16.33
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min000
|
84.00 bpm
Standard Deviation 13.81
|
76.94 bpm
Standard Deviation 15.05
|
79.94 bpm
Standard Deviation 16.86
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min010
|
85.17 bpm
Standard Deviation 13.44
|
77.25 bpm
Standard Deviation 14.75
|
79.61 bpm
Standard Deviation 16.75
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min015
|
84.33 bpm
Standard Deviation 13.97
|
78.00 bpm
Standard Deviation 14.01
|
77.89 bpm
Standard Deviation 17.33
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min020
|
83.00 bpm
Standard Deviation 13.84
|
76.44 bpm
Standard Deviation 14.77
|
79.28 bpm
Standard Deviation 17.28
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min025
|
83.83 bpm
Standard Deviation 14.61
|
77.13 bpm
Standard Deviation 13.61
|
77.06 bpm
Standard Deviation 17.12
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min030
|
83.94 bpm
Standard Deviation 14.21
|
76.69 bpm
Standard Deviation 14.38
|
78.83 bpm
Standard Deviation 17.57
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min040
|
83.06 bpm
Standard Deviation 13.98
|
77.88 bpm
Standard Deviation 14.42
|
77.56 bpm
Standard Deviation 18.10
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min050
|
83.65 bpm
Standard Deviation 14.28
|
76.67 bpm
Standard Deviation 13.28
|
79.50 bpm
Standard Deviation 18.06
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min060
|
83.59 bpm
Standard Deviation 13.86
|
78.13 bpm
Standard Deviation 12.88
|
78.56 bpm
Standard Deviation 17.12
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min070
|
82.53 bpm
Standard Deviation 13.73
|
77.07 bpm
Standard Deviation 12.66
|
77.11 bpm
Standard Deviation 17.27
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min080
|
84.76 bpm
Standard Deviation 13.37
|
76.47 bpm
Standard Deviation 15.08
|
76.89 bpm
Standard Deviation 17.83
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min090
|
83.82 bpm
Standard Deviation 12.73
|
77.80 bpm
Standard Deviation 14.36
|
76.22 bpm
Standard Deviation 17.13
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min100
|
84.29 bpm
Standard Deviation 12.46
|
78.53 bpm
Standard Deviation 12.82
|
75.94 bpm
Standard Deviation 16.31
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min110
|
85.18 bpm
Standard Deviation 12.54
|
76.73 bpm
Standard Deviation 11.66
|
75.44 bpm
Standard Deviation 16.76
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min120
|
83.71 bpm
Standard Deviation 11.97
|
78.47 bpm
Standard Deviation 13.52
|
78.39 bpm
Standard Deviation 20.37
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min130
|
83.59 bpm
Standard Deviation 12.50
|
77.33 bpm
Standard Deviation 12.66
|
75.94 bpm
Standard Deviation 15.69
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min140
|
81.76 bpm
Standard Deviation 11.99
|
77.60 bpm
Standard Deviation 12.79
|
75.28 bpm
Standard Deviation 16.35
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min150
|
82.06 bpm
Standard Deviation 13.38
|
79.67 bpm
Standard Deviation 11.79
|
76.06 bpm
Standard Deviation 15.42
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min160
|
83.41 bpm
Standard Deviation 11.49
|
78.73 bpm
Standard Deviation 11.81
|
79.33 bpm
Standard Deviation 16.11
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min170
|
83.88 bpm
Standard Deviation 11.19
|
79.07 bpm
Standard Deviation 13.57
|
76.44 bpm
Standard Deviation 18.07
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min180
|
82.12 bpm
Standard Deviation 10.34
|
77.53 bpm
Standard Deviation 13.72
|
78.56 bpm
Standard Deviation 16.76
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min190
|
83.24 bpm
Standard Deviation 12.40
|
79.40 bpm
Standard Deviation 15.08
|
76.89 bpm
Standard Deviation 16.36
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min200
|
83.41 bpm
Standard Deviation 11.37
|
79.27 bpm
Standard Deviation 13.42
|
80.00 bpm
Standard Deviation 15.98
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min210
|
81.24 bpm
Standard Deviation 11.68
|
80.27 bpm
Standard Deviation 14.39
|
77.50 bpm
Standard Deviation 15.57
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min220
|
82.94 bpm
Standard Deviation 12.29
|
79.93 bpm
Standard Deviation 14.10
|
77.33 bpm
Standard Deviation 16.83
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min230
|
84.47 bpm
Standard Deviation 12.96
|
79.87 bpm
Standard Deviation 15.06
|
78.78 bpm
Standard Deviation 16.75
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min240
|
85.29 bpm
Standard Deviation 12.01
|
79.40 bpm
Standard Deviation 13.74
|
78.56 bpm
Standard Deviation 16.85
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min000
|
86.28 bpm
Standard Deviation 11.96
|
82.44 bpm
Standard Deviation 14.81
|
78.11 bpm
Standard Deviation 16.91
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min005
|
80.39 bpm
Standard Deviation 12.46
|
80.80 bpm
Standard Deviation 15.81
|
80.29 bpm
Standard Deviation 16.13
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min010
|
80.78 bpm
Standard Deviation 12.74
|
78.67 bpm
Standard Deviation 1317
|
78.83 bpm
Standard Deviation 14.77
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min015
|
80.67 bpm
Standard Deviation 10.32
|
79.93 bpm
Standard Deviation 13.34
|
79.39 bpm
Standard Deviation 15.79
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min020
|
82.06 bpm
Standard Deviation 10.78
|
82.13 bpm
Standard Deviation 13.91
|
80.33 bpm
Standard Deviation 16.94
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min025
|
79.78 bpm
Standard Deviation 11.83
|
81.60 bpm
Standard Deviation 13.83
|
78.22 bpm
Standard Deviation 17.13
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min030
|
79.39 bpm
Standard Deviation 13.56
|
82.13 bpm
Standard Deviation 13.07
|
79.72 bpm
Standard Deviation 16.44
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min040
|
79.72 bpm
Standard Deviation 12.55
|
81.47 bpm
Standard Deviation 13.41
|
78.72 bpm
Standard Deviation 15.97
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min050
|
79.06 bpm
Standard Deviation 12.32
|
78.47 bpm
Standard Deviation 13.45
|
81.28 bpm
Standard Deviation 15.18
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min060
|
79.17 bpm
Standard Deviation 11.93
|
79.40 bpm
Standard Deviation 12.40
|
78.83 bpm
Standard Deviation 15.96
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min070
|
79.83 bpm
Standard Deviation 10.74
|
81.87 bpm
Standard Deviation 15.81
|
79.94 bpm
Standard Deviation 14.49
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min080
|
78.44 bpm
Standard Deviation 10.92
|
83.87 bpm
Standard Deviation 11.54
|
80.33 bpm
Standard Deviation 16.22
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min090
|
79.11 bpm
Standard Deviation 12.36
|
82.33 bpm
Standard Deviation 12.82
|
79.22 bpm
Standard Deviation 17.16
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min100
|
79.17 bpm
Standard Deviation 12.66
|
84.67 bpm
Standard Deviation 12.58
|
80.00 bpm
Standard Deviation 16.95
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min110
|
79.67 bpm
Standard Deviation 11.74
|
82.80 bpm
Standard Deviation 13.61
|
80.61 bpm
Standard Deviation 16.55
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min120
|
79.56 bpm
Standard Deviation 11.98
|
83.47 bpm
Standard Deviation 13.44
|
80.00 bpm
Standard Deviation 16.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hoursPopulation: Includes all subjects during Phase 1 (i.e., infusion 1)
Infusion 2 (Day 14) - Heart rate at all time points by group "Phase" in this analysis refers to the infusion stage as defined in the protocol.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=14 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Heart Rate Per Infusion Phase by Group
Phase 1 - min000s1
|
77.38 bpm
Standard Deviation 11.77
|
75.08 bpm
Standard Deviation 13.94
|
76.94 bpm
Standard Deviation 18.50
|
|
Heart Rate Per Infusion Phase by Group
Phase 1 - min005s1
|
79.69 bpm
Standard Deviation 12.43
|
76.77 bpm
Standard Deviation 14.86
|
78.67 bpm
Standard Deviation 17.85
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min000
|
81.06 bpm
Standard Deviation 11.25
|
77.77 bpm
Standard Deviation 15.24
|
78.72 bpm
Standard Deviation 17.75
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min005
|
82.31 bpm
Standard Deviation 12.88
|
81.38 bpm
Standard Deviation 15.32
|
76.39 bpm
Standard Deviation 17.77
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min010
|
81.50 bpm
Standard Deviation 13.46
|
80.62 bpm
Standard Deviation 16.44
|
77.12 bpm
Standard Deviation 17.19
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min015
|
81.38 bpm
Standard Deviation 12.99
|
80.92 bpm
Standard Deviation 15.40
|
76.06 bpm
Standard Deviation 17.11
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min020
|
82.06 bpm
Standard Deviation 12.13
|
79.69 bpm
Standard Deviation 16.73
|
74.89 bpm
Standard Deviation 16.97
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min025
|
82.31 bpm
Standard Deviation 12.35
|
80.69 bpm
Standard Deviation 18.08
|
76.22 bpm
Standard Deviation 16.81
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min030
|
81.50 bpm
Standard Deviation 10.22
|
81.15 bpm
Standard Deviation 16.32
|
76.17 bpm
Standard Deviation 15.73
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min040
|
79.88 bpm
Standard Deviation 13.61
|
81.69 bpm
Standard Deviation 15.50
|
76.72 bpm
Standard Deviation 15.35
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min050
|
80.25 bpm
Standard Deviation 12.23
|
78.85 bpm
Standard Deviation 15.42
|
75.00 bpm
Standard Deviation 16.30
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min060
|
79.69 bpm
Standard Deviation 15.12
|
79.69 bpm
Standard Deviation 14.63
|
75.50 bpm
Standard Deviation 15.75
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min070
|
81.69 bpm
Standard Deviation 13.85
|
81.31 bpm
Standard Deviation 13.53
|
75.06 bpm
Standard Deviation 16.28
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min080
|
79.44 bpm
Standard Deviation 13.93
|
80.23 bpm
Standard Deviation 14.11
|
75.39 bpm
Standard Deviation 14.61
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min090
|
78.00 bpm
Standard Deviation 14.58
|
79.58 bpm
Standard Deviation 14.71
|
73.78 bpm
Standard Deviation 15.56
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min100
|
79.94 bpm
Standard Deviation 14.29
|
78.17 bpm
Standard Deviation 14.66
|
76.11 bpm
Standard Deviation 15.15
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min110
|
83.33 bpm
Standard Deviation 11.58
|
80.15 bpm
Standard Deviation 15.51
|
75.17 bpm
Standard Deviation 15.52
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min120
|
82.47 bpm
Standard Deviation 12.97
|
81.25 bpm
Standard Deviation 16.16
|
74.56 bpm
Standard Deviation 14.27
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min130
|
82.13 bpm
Standard Deviation 13.03
|
78.75 bpm
Standard Deviation 15.24
|
75.11 bpm
Standard Deviation 13.60
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min140
|
81.73 bpm
Standard Deviation 13.95
|
80.69 bpm
Standard Deviation 14.92
|
75.89 bpm
Standard Deviation 15.87
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min150
|
81.40 bpm
Standard Deviation 12.57
|
78.75 bpm
Standard Deviation 13.59
|
75.78 bpm
Standard Deviation 14.53
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min160
|
81.53 bpm
Standard Deviation 13.20
|
80.00 bpm
Standard Deviation 11.26
|
75.33 bpm
Standard Deviation 13.75
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min170
|
81.60 bpm
Standard Deviation 14.46
|
78.75 bpm
Standard Deviation 12.55
|
75.06 bpm
Standard Deviation 14.43
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min180
|
80.00 bpm
Standard Deviation 12.91
|
81.25 bpm
Standard Deviation 12.81
|
74.78 bpm
Standard Deviation 14.10
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min190
|
80.93 bpm
Standard Deviation 12.91
|
80.58 bpm
Standard Deviation 16.37
|
73.94 bpm
Standard Deviation 14.18
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min200
|
81.60 bpm
Standard Deviation 14.39
|
80.33 bpm
Standard Deviation 14.27
|
75.00 bpm
Standard Deviation 12.63
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min210
|
84.73 bpm
Standard Deviation 11.93
|
80.75 bpm
Standard Deviation 17.12
|
75.33 bpm
Standard Deviation 15.04
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min220
|
84.07 bpm
Standard Deviation 12.55
|
79.92 bpm
Standard Deviation 13.92
|
74.61 bpm
Standard Deviation 14.46
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min230
|
85.07 bpm
Standard Deviation 11.78
|
78.00 bpm
Standard Deviation 14.59
|
77.56 bpm
Standard Deviation 14.61
|
|
Heart Rate Per Infusion Phase by Group
Phase 2 - min240
|
82.53 bpm
Standard Deviation 13.73
|
80.42 bpm
Standard Deviation 12.55
|
76.72 bpm
Standard Deviation 15.69
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min000
|
81.50 bpm
Standard Deviation 13.85
|
79.25 bpm
Standard Deviation 14.77
|
76.22 bpm
Standard Deviation 16.13
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min005
|
77.44 bpm
Standard Deviation 12.19
|
73.25 bpm
Standard Deviation 13.97
|
79.06 bpm
Standard Deviation 16.00
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min010
|
77.38 bpm
Standard Deviation 13.64
|
73.75 bpm
Standard Deviation 13.60
|
77.78 bpm
Standard Deviation 15.38
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min015
|
75.13 bpm
Standard Deviation 13.59
|
75.17 bpm
Standard Deviation 12.71
|
78.83 bpm
Standard Deviation 14.50
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min020
|
78.88 bpm
Standard Deviation 13.72
|
76.92 bpm
Standard Deviation 11.24
|
78.39 bpm
Standard Deviation 14.74
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min025
|
79.25 bpm
Standard Deviation 12.46
|
75.75 bpm
Standard Deviation 14.14
|
77.44 bpm
Standard Deviation 12.87
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min030
|
80.31 bpm
Standard Deviation 11.16
|
74.83 bpm
Standard Deviation 11.76
|
78.33 bpm
Standard Deviation 13.92
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min040
|
80.63 bpm
Standard Deviation 16.66
|
74.92 bpm
Standard Deviation 10.42
|
78.39 bpm
Standard Deviation 13.85
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min050
|
79.00 bpm
Standard Deviation 11.89
|
75.67 bpm
Standard Deviation 12.20
|
78.33 bpm
Standard Deviation 14.58
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min060
|
78.00 bpm
Standard Deviation 11.35
|
77.08 bpm
Standard Deviation 13.21
|
79.11 bpm
Standard Deviation 13.64
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min070
|
78.81 bpm
Standard Deviation 11.12
|
77.75 bpm
Standard Deviation 13.92
|
77.50 bpm
Standard Deviation 13.95
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min080
|
80.69 bpm
Standard Deviation 10.87
|
75.92 bpm
Standard Deviation 14.85
|
78.06 bpm
Standard Deviation 14.94
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min090
|
80.25 bpm
Standard Deviation 10.07
|
78.42 bpm
Standard Deviation 16.55
|
78.89 bpm
Standard Deviation 14.29
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min100
|
80.06 bpm
Standard Deviation 10.51
|
79.75 bpm
Standard Deviation 16.80
|
80.17 bpm
Standard Deviation 14.29
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min110
|
79.88 bpm
Standard Deviation 10.25
|
77.50 bpm
Standard Deviation 16.94
|
80.22 bpm
Standard Deviation 14.72
|
|
Heart Rate Per Infusion Phase by Group
Post Infusion - min120
|
80.19 bpm
Standard Deviation 11.73
|
80.83 bpm
Standard Deviation 17.02
|
78.44 bpm
Standard Deviation 14.30
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 - Baseline (pre-infusion), During Infusion (@30 min), Post-Infusion (@60min)Population: All subjects receiving a complete or partial Phase 1 infusion
Infusion 1 (Day 0) - ECG measures at all time points by group
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
ECG Measures at All Time Points by Group
Baseline_PR Interval
|
162.84 mm/sec
Standard Deviation 30.09
|
149.11 mm/sec
Standard Deviation 11.52
|
164.56 mm/sec
Standard Deviation 19.61
|
|
ECG Measures at All Time Points by Group
Baseline_QRS Interval
|
91.37 mm/sec
Standard Deviation 11.37
|
86.89 mm/sec
Standard Deviation 8.76
|
88.11 mm/sec
Standard Deviation 10.12
|
|
ECG Measures at All Time Points by Group
Baseline_QT Interval
|
380.16 mm/sec
Standard Deviation 26.60
|
384.28 mm/sec
Standard Deviation 31.47
|
381.94 mm/sec
Standard Deviation 36.50
|
|
ECG Measures at All Time Points by Group
Baseline_RR Interval
|
0.81 mm/sec
Standard Deviation 0.19
|
0.82 mm/sec
Standard Deviation 0.15
|
0.81 mm/sec
Standard Deviation 0.19
|
|
ECG Measures at All Time Points by Group
30min_PR Interval
|
159.63 mm/sec
Standard Deviation 34.81
|
152.40 mm/sec
Standard Deviation 12.44
|
167.59 mm/sec
Standard Deviation 21.30
|
|
ECG Measures at All Time Points by Group
30min_QRS Interval
|
89.79 mm/sec
Standard Deviation 11.22
|
88.00 mm/sec
Standard Deviation 10.39
|
89.12 mm/sec
Standard Deviation 9.97
|
|
ECG Measures at All Time Points by Group
30min_QT Interval
|
385.11 mm/sec
Standard Deviation 25.55
|
385.27 mm/sec
Standard Deviation 29.72
|
385.53 mm/sec
Standard Deviation 42.92
|
|
ECG Measures at All Time Points by Group
30min_RR Interval
|
0.76 mm/sec
Standard Deviation 0.12
|
0.81 mm/sec
Standard Deviation 0.16
|
0.81 mm/sec
Standard Deviation 0.20
|
|
ECG Measures at All Time Points by Group
End_PR Interval
|
165.94 mm/sec
Standard Deviation 38.63
|
149.43 mm/sec
Standard Deviation 11.33
|
165.63 mm/sec
Standard Deviation 25.23
|
|
ECG Measures at All Time Points by Group
End_QRS Interval
|
91.67 mm/sec
Standard Deviation 13.43
|
87.50 mm/sec
Standard Deviation 9.63
|
89.00 mm/sec
Standard Deviation 10.09
|
|
ECG Measures at All Time Points by Group
End_QT Interval
|
371.94 mm/sec
Standard Deviation 41.97
|
377.00 mm/sec
Standard Deviation 25.33
|
391.13 mm/sec
Standard Deviation 43.35
|
|
ECG Measures at All Time Points by Group
End_RR Interval
|
0.79 mm/sec
Standard Deviation 0.12
|
0.80 mm/sec
Standard Deviation 0.11
|
0.82 mm/sec
Standard Deviation 0.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14 - Baseline (pre-infusion), During Infusion (@30 min), Post-Infusion (@60min)Population: All subjects receiving a complete or partial Phase 2 infusion
Infusion 2 (Day 14) - ECG measures at all time points by group
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=14 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
ECG Measures at All Time Points by Group
Baseline_PR Interval
|
155.47 mm/sec
Standard Deviation 23.46
|
149.46 mm/sec
Standard Deviation 15.61
|
167.61 mm/sec
Standard Deviation 20.02
|
|
ECG Measures at All Time Points by Group
Baseline_QRS Interval
|
92.82 mm/sec
Standard Deviation 11.29
|
86.46 mm/sec
Standard Deviation 10.05
|
91.33 mm/sec
Standard Deviation 12.45
|
|
ECG Measures at All Time Points by Group
Baseline_QT Interval
|
379.35 mm/sec
Standard Deviation 29.59
|
385.69 mm/sec
Standard Deviation 35.84
|
387.33 mm/sec
Standard Deviation 38.27
|
|
ECG Measures at All Time Points by Group
Baseline_RR Interval
|
0.80 mm/sec
Standard Deviation 0.17
|
0.86 mm/sec
Standard Deviation 0.16
|
0.84 mm/sec
Standard Deviation 0.19
|
|
ECG Measures at All Time Points by Group
30min_PR Interval
|
156.18 mm/sec
Standard Deviation 21.95
|
146.69 mm/sec
Standard Deviation 14.85
|
172.00 mm/sec
Standard Deviation 19.76
|
|
ECG Measures at All Time Points by Group
30min_QRS Interval
|
90.18 mm/sec
Standard Deviation 11.95
|
87.00 mm/sec
Standard Deviation 7.98
|
88.44 mm/sec
Standard Deviation 10.76
|
|
ECG Measures at All Time Points by Group
30min_QT Interval
|
389.18 mm/sec
Standard Deviation 25.33
|
360.08 mm/sec
Standard Deviation 46.52
|
380.44 mm/sec
Standard Deviation 33.30
|
|
ECG Measures at All Time Points by Group
30min_RR Interval
|
0.75 mm/sec
Standard Deviation 0.11
|
0.77 mm/sec
Standard Deviation 0.18
|
0.82 mm/sec
Standard Deviation 0.18
|
|
ECG Measures at All Time Points by Group
End_PR Interval
|
160.41 mm/sec
Standard Deviation 26.48
|
153.55 mm/sec
Standard Deviation 19.87
|
165.63 mm/sec
Standard Deviation 21.08
|
|
ECG Measures at All Time Points by Group
End_QRS Interval
|
95.41 mm/sec
Standard Deviation 9.90
|
86.64 mm/sec
Standard Deviation 9.90
|
89.50 mm/sec
Standard Deviation 9.97
|
|
ECG Measures at All Time Points by Group
End_QT Interval
|
387.06 mm/sec
Standard Deviation 38.89
|
384.91 mm/sec
Standard Deviation 29.89
|
383.25 mm/sec
Standard Deviation 31.60
|
|
ECG Measures at All Time Points by Group
End_RR Interval
|
0.80 mm/sec
Standard Deviation 0.16
|
0.86 mm/sec
Standard Deviation 0.11
|
0.81 mm/sec
Standard Deviation 0.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The period of observation for collection of treatment-emergent adverse events extends from Day 0 treatment through the final visit at Day 28.Population: Number of Treatment-Emergent Adverse Events (TEAEs) in Each Treatment Group
Incidence of Treatment-Emergent Adverse Events (TEAE) by Treatment Group. A treatment emergent adverse event (TEAE) is an AE that either began following initiation of study treatment or was present prior to the initiation of the treatment, but increased in frequency or severity following initiation treatment, regardless of causality.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
|
13 # of TEAEs
|
8 # of TEAEs
|
10 # of TEAEs
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The period of observation extends from Day 0 treatment through the final visit at Day 28Population: All subjects withdrawn from the study due to TEAEs
Incidence of Treatment-Emergent Adverse Events (TEAE) by Treatment Group. A treatment emergent adverse event (TEAE) is an AE that either began following initiation of study treatment or was present prior to the initiation of the treatment, but increased in frequency or severity following initiation treatment, regardless of causality.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Number of Subject Withdrawals Due to Treatment-Emergent Adverse Events (TEAEs)
|
3 participants
|
4 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day - 1), Follow-Up = reported at any assessment thereafter, including 7 hours after Infusions #1 and #2, Baseline 2 (Day 13) and final follow-up, including early termination visits.Population: Includes all subjects with SAFTEE data
The Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI): This is a self-rated 77-item questionnaire organized into 13 body areas assessing possible adverse events during the course of the trial.
Outcome measures
| Measure |
Drug
n=18 Participants
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo
n=16 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo:
|
Placebo - Placebo
n=18 Participants
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
10. Baseline - Hearing or seeing things
|
22.2 percentage of participants
|
25.0 percentage of participants
|
22.2 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
10. Follow-Up - Hearing or seeing things
|
33.3 percentage of participants
|
31.3 percentage of participants
|
16.7 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
3. Baseline - Feeling drowsy or sleepy
|
16.7 percentage of participants
|
0.0 percentage of participants
|
22.2 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
3. Follow-Up - Feeling drowsy or sleepy
|
22.2 percentage of participants
|
25.0 percentage of participants
|
22.2 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
8. Baseline - Trouble concentrating
|
16.7 percentage of participants
|
6.3 percentage of participants
|
22.2 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
8. Follow-Up - Trouble concentrating
|
11.1 percentage of participants
|
18.8 percentage of participants
|
27.8 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
7. Baseline - Poor memory
|
11.1 percentage of participants
|
6.3 percentage of participants
|
27.8 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
7. Follow-Up - Poor memory
|
5.6 percentage of participants
|
25.0 percentage of participants
|
22.2 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
1. Baseline - Trouble Sleeping
|
16.7 percentage of participants
|
6.3 percentage of participants
|
27.8 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
1. Follow-Up - Trouble Sleeping
|
11.1 percentage of participants
|
12.5 percentage of participants
|
22.2 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
4. Baseline - Feeling nervous or hyper
|
5.6 percentage of participants
|
18.8 percentage of participants
|
33.3 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
4. Follow-Up - Feeling nervous or hyper
|
5.6 percentage of participants
|
18.8 percentage of participants
|
22.2 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
18. Baseline - Dry mouth
|
5.6 percentage of participants
|
12.5 percentage of participants
|
11.1 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
18. Follow-Up - Dry mouth
|
5.6 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
34. Baseline - Frequent need to urinate
|
0.0 percentage of participants
|
6.3 percentage of participants
|
11.1 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
34. Follow-Up - Frequent need to urinate
|
5.6 percentage of participants
|
18.8 percentage of participants
|
16.7 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
17. Baseline - Stuffy nose
|
5.6 percentage of participants
|
6.3 percentage of participants
|
16.7 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
17. Follow-Up - Stuffy nose
|
5.6 percentage of participants
|
18.8 percentage of participants
|
11.1 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
52. Baseline - Hot flashes
|
0.0 percentage of participants
|
6.3 percentage of participants
|
5.6 percentage of participants
|
|
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at "Moderate" or "Severe" Level for the 10 Most Frequently Reported Symptoms Post Randomization
52. Follow-Up - Hot flashes
|
11.1 percentage of participants
|
6.3 percentage of participants
|
16.7 percentage of participants
|
Adverse Events
Drug - Drug
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo - Drug
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo - Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Drug - Drug
n=23 participants at risk
Phase 1 - intravenous sodium nitroprusside Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo - Drug
n=19 participants at risk
Phase 1 - intravenous dextrose Phase 2 - intravenous sodium nitroprusside
sodium nitroprusside: intravenous
|
Placebo - Placebo
n=18 participants at risk
Phase 1 - intravenous dextrose Phase 2 - intravenous dextrose
Placebo: Placebo
|
|---|---|---|---|
|
Cardiac disorders
Hypotension
|
21.7%
5/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
10.5%
2/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
15.8%
3/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
11.1%
2/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
11.1%
2/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Low O2 Saturation Rate
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
10.5%
2/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
2/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Cardiac disorders
Abnormal ECG
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Reproductive system and breast disorders
Decreased Libido
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Vascular disorders
Dizziness
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
General disorders
Lightheadedness
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
11.1%
2/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Vascular disorders
Flushing
|
8.7%
2/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
10.5%
2/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Gastrointestinal disorders
Increased Appetite
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
General disorders
Drowsiness
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
General disorders
Dry Mouth
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Psychiatric disorders
Feeling Nervous or Hyperactive
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Vascular disorders
Hot Flashes
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Cardiac disorders
Irregular Heart Activity
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
General disorders
Pelvic Pain
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Nervous system disorders
Tingling
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Immune system disorders
White Blood Cell Decrease
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Hepatobiliary disorders
Elevated ALT Levels
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.6%
1/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
General disorders
Heat Exhaustion
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Psychiatric disorders
Hypersomnia
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Cardiac disorders
Increased Heart Rate
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
5.3%
1/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
|
Cardiac disorders
Hypertension
|
4.3%
1/23 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/19 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
0.00%
0/18 • The period of observation for collection of adverse events extends from the time the subject gave informed consent until the final visit at Day 28.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place