Trial Outcomes & Findings for Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly (NCT NCT01384591)
NCT ID: NCT01384591
Last Updated: 2018-05-08
Results Overview
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.
COMPLETED
PHASE1/PHASE2
6 participants
Baseline
2018-05-08
Participant Flow
Participant milestones
| Measure |
Losartan and Placebo N-acetylcysteine
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Placebo Losartan and Placebo N-acetylcysteine
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly
Baseline characteristics by cohort
| Measure |
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Continuous
|
75.2 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
72.3 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
68.5 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
72 years
STANDARD_DEVIATION 3.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Total Mass
|
67.1 kilograms
STANDARD_DEVIATION 10.2 • n=5 Participants
|
72.7 kilograms
STANDARD_DEVIATION 11.4 • n=7 Participants
|
65.7 kilograms
STANDARD_DEVIATION 3.5 • n=5 Participants
|
68.5 kilograms
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Lean Body Mass
|
41.2 kilograms
STANDARD_DEVIATION 11.1 • n=5 Participants
|
52.9 kilograms
STANDARD_DEVIATION 14.2 • n=7 Participants
|
45.9 kilograms
STANDARD_DEVIATION 2.4 • n=5 Participants
|
46.7 kilograms
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Fat Mass
|
23.7 kilograms
STANDARD_DEVIATION 0.98 • n=5 Participants
|
16.6 kilograms
STANDARD_DEVIATION 3.2 • n=7 Participants
|
16.8 kilograms
STANDARD_DEVIATION 0.490 • n=5 Participants
|
19.1 kilograms
STANDARD_DEVIATION 3.90 • n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineFemoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Leg Blood Flow as Measured by Doppler Ultrasound
|
174.99 ml/minute
Standard Deviation 176.02
|
102.08 ml/minute
Standard Deviation 3.42
|
428.45 ml/minute
Standard Deviation 114.57
|
PRIMARY outcome
Timeframe: 12 hours post dose one of the interventionFemoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Leg Blood Flow as Measured by Doppler Ultrasound
|
181.88 ml/minute
Standard Deviation 204.92
|
69.83 ml/minute
Standard Deviation 77.57
|
91.68 ml/minute
Standard Deviation 4.88
|
PRIMARY outcome
Timeframe: 1 hour post dose two of the intervention, average of 13 hours post dose 1 of the interventionPopulation: Missed blood flow measurement on one placebo participant at this time point.
Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=1 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Leg Blood Flow as Measured by Doppler Ultrasound
|
105.80 ml/minute
|
90.06 ml/minute
Standard Deviation 39.19
|
95.60 ml/minute
Standard Deviation 64.67
|
PRIMARY outcome
Timeframe: 2 hours post dose two of the intervention, average of 14 hours post dose one of the interventionFemoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Leg Blood Flow as Measured by Doppler Ultrasound
|
214.56 ml/minute
Standard Deviation 88.42
|
70.37 ml/minute
Standard Deviation 15.35
|
114.34 ml/minute
Standard Deviation 38.71
|
PRIMARY outcome
Timeframe: Post dose three of the intervention and a meal, average of 17 hours post dose one of the interventionFemoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Leg Blood Flow as Measured by Doppler Ultrasound
|
158.71 ml/minute
Standard Deviation 83.85
|
109.94 ml/minute
Standard Deviation 59.51
|
153.38 ml/minute
Standard Deviation 103.37
|
PRIMARY outcome
Timeframe: 1 hour post dose three of the intervention and a meal, average of 18 hours post dose one of the interventionFemoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Leg Blood Flow as Measured by Doppler Ultrasound
|
84.41 ml/minute
Standard Deviation 18.57
|
104.40 ml/minute
Standard Deviation 56.55
|
152.10 ml/minute
Standard Deviation 46.59
|
PRIMARY outcome
Timeframe: 2 hours post dose three of the intervention and a meal, average of 19 hours post dose one of the interventionFemoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Leg Blood Flow as Measured by Doppler Ultrasound
|
70.60 ml/minute
Standard Deviation 17.46
|
128.78 ml/minute
Standard Deviation 123.74
|
57.79 ml/minute
Standard Deviation 29.24
|
SECONDARY outcome
Timeframe: baselineHandgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline
|
21.5 kilograms
Standard Deviation 6.5
|
23.2 kilograms
Standard Deviation 4.9
|
20.5 kilograms
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: baselineHandgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline
|
24.2 kilograms
Standard Deviation 2.6
|
19.3 kilograms
Standard Deviation 1.9
|
17.0 kilograms
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: baselineHandgrip Strength of dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline
|
45.2 kilograms
Standard Deviation 8.2
|
33.2 kilograms
Standard Deviation 4.0
|
28.8 kilograms
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: baselineHandgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline
|
47.1 kilograms
Standard Deviation 7.9
|
31.1 kilograms
Standard Deviation 0.8
|
26.5 kilograms
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for 2 subjects wasn't recorded.
Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction after fatigue test.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=1 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=1 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline
|
129.6 % of Maximal Voluntary Contraction
|
94.2 % of Maximal Voluntary Contraction
Standard Deviation 12.06
|
103.4 % of Maximal Voluntary Contraction
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for 2 subjects was not recorded.
Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=1 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=1 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline
|
64.55 % of Maximal Voluntary Contraction
|
83.62 % of Maximal Voluntary Contraction
Standard Deviation 2.33
|
90.29 % of Maximal Voluntary Contraction
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionHandgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention
|
21.2 kilograms
Standard Deviation 13.9
|
15.8 kilograms
Standard Deviation 1.6
|
16.2 kilograms
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionHandgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention
|
17.8 kilograms
Standard Deviation 4.5
|
14.8 kilograms
Standard Deviation 4.5
|
13.7 kilograms
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionHandgrip Strength of dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention
|
44.1 kilograms
Standard Deviation 6.2
|
31.3 kilograms
Standard Deviation 6.6
|
24.2 kilograms
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionHandgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention
|
42.3 kilograms
Standard Deviation 3.9
|
28.6 kilograms
Standard Deviation 2.7
|
30.2 kilograms
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionPopulation: Data for 2 subjects not recorded.
Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=1 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=1 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention
|
101.0 % of Maximal Voluntary Contraction
|
95.97 % of Maximal Voluntary Contraction
Standard Deviation 2.16
|
111 % of Maximal Voluntary Contraction
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionPopulation: Data from 2 subjects was not recorded.
Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=1 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=1 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention
|
88.61 % of Maximal Voluntary Contraction
|
93.25 % of Maximal Voluntary Contraction
Standard Deviation 11.32
|
95.60 % of Maximal Voluntary Contraction
|
SECONDARY outcome
Timeframe: BaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline
|
0 units on a scale
Standard Deviation 0
|
1.5 units on a scale
Standard Deviation 2.12
|
3.5 units on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention
|
0 units on a scale
Standard Deviation 0
|
2 units on a scale
Standard Deviation 2.8
|
6.5 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: BaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline
|
0.5 units on a scale
Standard Deviation 0.7
|
0.5 units on a scale
Standard Deviation 0.7
|
3 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention
|
0 units on a scale
Standard Deviation 0
|
0.5 units on a scale
Standard Deviation 0.7
|
7 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: BaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline
|
0.5 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0
|
4 units on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention
|
0.5 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0
|
7.5 units on a scale
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: BaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline
|
0.5 units on a scale
Standard Deviation 0.7
|
0.5 units on a scale
Standard Deviation 0.7
|
4.5 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention
|
0 units on a scale
Standard Deviation 0
|
1 units on a scale
Standard Deviation 1.4
|
6.5 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: BaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the vigor scale is 0 to 24, with the higher number meaning more vigor. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline
|
18 units on a scale
Standard Deviation 0
|
15 units on a scale
Standard Deviation 2.8
|
16.5 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the vigor scale is 0 to 24, with the higher number meaning more vigor. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention
|
20.5 units on a scale
Standard Deviation 3.5
|
15.5 units on a scale
Standard Deviation 3.5
|
14 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: BaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline
|
-16.5 units on a scale
Standard Deviation 2.12
|
-12.5 units on a scale
Standard Deviation 6.36
|
-1.5 units on a scale
Standard Deviation 4.95
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention
|
-20 units on a scale
Standard Deviation 2.8
|
-12 units on a scale
Standard Deviation 1.4
|
13.5 units on a scale
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: BaselineThe Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score ranges (0 to 10) with higher score indicating a worse outcome.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Global Fatigue Score as Measured by Brief Fatigue Inventory at Baseline
|
0.55 units on a scale
Standard Deviation 0.78
|
0.38 units on a scale
Standard Deviation 0.39
|
1.11 units on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one interventionThe Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score range 0 to 10, with a higher score indicating a worse outcome.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Global Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention
|
0.5 units on a scale
Standard Deviation 0.7
|
0.22 units on a scale
Standard Deviation 0.31
|
1.19 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: baseline - before handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.
|
0.3 units on a scale
Standard Deviation 0.14
|
3.3 units on a scale
Standard Deviation 2.69
|
0.2 units on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: baseline - directly after handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.
|
2.7 units on a scale
Standard Deviation 3.39
|
7.5 units on a scale
Standard Deviation 4.5
|
0.6 units on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention
|
1.45 units on a scale
Standard Deviation 1.62
|
1 units on a scale
Standard Deviation 1.41
|
0.65 units on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue testPopulation: Data for 1 subject was not collected.
The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=1 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention
|
3.4 units on a scale
Standard Deviation 4.38
|
11 units on a scale
|
0.75 units on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: baseline - before handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.
|
0.4 units on a scale
Standard Deviation 0.14
|
1.15 units on a scale
Standard Deviation 0.35
|
0.55 units on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: baseline - directly after handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.
|
1.05 units on a scale
Standard Deviation 1.20
|
5 units on a scale
Standard Deviation 3.11
|
0.6 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention
|
0.7 units on a scale
Standard Deviation 0.42
|
4.1 units on a scale
Standard Deviation 4.1
|
0.55 units on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue testPopulation: Data for 1 subject was not recorded
The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Outcome measures
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 Participants
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=1 Participants
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 Participants
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention
|
1.25 units on a scale
Standard Deviation 1.34
|
5.3 units on a scale
|
0.95 units on a scale
Standard Deviation 1.34
|
Adverse Events
Placebo Losartan and Placebo N-acetylcysteine
N-acetylcysteine and Placebo Losartan
Losartan and Placebo N-acetylcysteine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Losartan and Placebo N-acetylcysteine
n=2 participants at risk
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
N-acetylcysteine and Placebo Losartan
n=2 participants at risk
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
Losartan and Placebo N-acetylcysteine
n=2 participants at risk
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
Additional Information
Melinda Sheffield-Moore
University of Texas Medical Branch
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place