Trial Outcomes & Findings for Losartan for the Treatment of Pediatric NAFLD (NCT NCT03467217)
NCT ID: NCT03467217
Last Updated: 2021-10-21
Results Overview
Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2021-10-21
Participant Flow
Participant milestones
| Measure |
Losartan
100 mg losartan once per day
|
Placebo
Matching placebo, taken once per day
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
40
|
|
Overall Study
COMPLETED
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
Losartan
100 mg losartan once per day
|
Placebo
Matching placebo, taken once per day
|
|---|---|---|
|
Overall Study
Trial stopped early
|
5
|
2
|
|
Overall Study
Clinic closed due to COVID-19 pandemic
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Losartan for the Treatment of Pediatric NAFLD
Baseline characteristics by cohort
| Measure |
Losartan Potassium Capsule
n=43 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=40 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 2 • n=99 Participants
|
13 years
STANDARD_DEVIATION 2 • n=107 Participants
|
13 years
STANDARD_DEVIATION 2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Alanine aminotransferase
|
115 U/L
STANDARD_DEVIATION 50 • n=99 Participants
|
126 U/L
STANDARD_DEVIATION 61 • n=107 Participants
|
120 U/L
STANDARD_DEVIATION 55 • n=206 Participants
|
|
Aspartate aminotransferase
|
59 U/L
STANDARD_DEVIATION 26 • n=99 Participants
|
70 U/L
STANDARD_DEVIATION 38 • n=107 Participants
|
64 U/L
STANDARD_DEVIATION 33 • n=206 Participants
|
|
Alkaline phosphate
|
192 U/L
STANDARD_DEVIATION 114 • n=99 Participants
|
202 U/L
STANDARD_DEVIATION 99 • n=107 Participants
|
197 U/L
STANDARD_DEVIATION 106 • n=206 Participants
|
|
y-Glutamyltransferase
|
53 U/L
STANDARD_DEVIATION 44 • n=99 Participants
|
51 U/L
STANDARD_DEVIATION 28 • n=107 Participants
|
52 U/L
STANDARD_DEVIATION 37 • n=206 Participants
|
|
Total bilirubin
|
0.6 mg/dL
STANDARD_DEVIATION 0.3 • n=99 Participants
|
0.6 mg/dL
STANDARD_DEVIATION 0.3 • n=107 Participants
|
0.6 mg/dL
STANDARD_DEVIATION 0.3 • n=206 Participants
|
|
Direct bilirubin
|
0.1 mg/dL
STANDARD_DEVIATION 0.1 • n=99 Participants
|
0.1 mg/dL
STANDARD_DEVIATION 0.1 • n=107 Participants
|
0.1 mg/dL
STANDARD_DEVIATION 0.1 • n=206 Participants
|
|
Total cholesterol
|
159 mg/dL
STANDARD_DEVIATION 44 • n=99 Participants
|
155 mg/dL
STANDARD_DEVIATION 31 • n=107 Participants
|
157 mg/dL
STANDARD_DEVIATION 38 • n=206 Participants
|
|
High-density lipoprotein
|
39 mg/uL
STANDARD_DEVIATION 7 • n=99 Participants
|
41 mg/uL
STANDARD_DEVIATION 9 • n=107 Participants
|
40 mg/uL
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Low-density lipoprotein
|
91 mg/uL
STANDARD_DEVIATION 40 • n=99 Participants
|
92 mg/uL
STANDARD_DEVIATION 22 • n=107 Participants
|
91 mg/uL
STANDARD_DEVIATION 32 • n=206 Participants
|
|
Triglycerides
|
158 mg/dL
STANDARD_DEVIATION 105 • n=99 Participants
|
128 mg/dL
STANDARD_DEVIATION 58 • n=107 Participants
|
143 mg/dL
STANDARD_DEVIATION 87 • n=206 Participants
|
|
Fasting serum glucose
|
91 mg/dL
n=99 Participants
|
87 mg/dL
n=107 Participants
|
89 mg/dL
n=206 Participants
|
|
Insulin
|
29 umol/mL
n=99 Participants
|
38 umol/mL
n=107 Participants
|
32 umol/mL
n=206 Participants
|
|
Homeostasis model assessment (HOMA) score of insulin resistance
|
6.5 mg/dL x umol/mL/405
n=99 Participants
|
8.3 mg/dL x umol/mL/405
n=107 Participants
|
7.1 mg/dL x umol/mL/405
n=206 Participants
|
|
Hemoglobin A1c
|
5.4 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.6 • n=99 Participants
|
5.4 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.3 • n=107 Participants
|
5.4 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.5 • n=206 Participants
|
|
Height
|
165 cm
STANDARD_DEVIATION 9 • n=99 Participants
|
165 cm
STANDARD_DEVIATION 9 • n=107 Participants
|
165 cm
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Weight
|
95 kg
STANDARD_DEVIATION 17 • n=99 Participants
|
96 kg
STANDARD_DEVIATION 19 • n=107 Participants
|
95 kg
STANDARD_DEVIATION 18 • n=206 Participants
|
|
Body-mass index
|
34 kg/m^2
STANDARD_DEVIATION 5 • n=99 Participants
|
35 kg/m^2
STANDARD_DEVIATION 5 • n=107 Participants
|
35 kg/m^2
STANDARD_DEVIATION 5 • n=206 Participants
|
|
Mid arm circumference
|
33 cm
STANDARD_DEVIATION 4 • n=99 Participants
|
33 cm
STANDARD_DEVIATION 4 • n=107 Participants
|
33 cm
STANDARD_DEVIATION 4 • n=206 Participants
|
|
Waist circumference
|
108 cm
STANDARD_DEVIATION 11 • n=99 Participants
|
111 cm
STANDARD_DEVIATION 11 • n=107 Participants
|
110 cm
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Hip circumference
|
110 cm
STANDARD_DEVIATION 11 • n=99 Participants
|
112 cm
STANDARD_DEVIATION 11 • n=107 Participants
|
111 cm
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Waist to hip ratio
|
0.99 ratio
STANDARD_DEVIATION 0.06 • n=99 Participants
|
0.99 ratio
STANDARD_DEVIATION 0.06 • n=107 Participants
|
0.99 ratio
STANDARD_DEVIATION 0.06 • n=206 Participants
|
|
Systolic blood pressure
|
121 mmHg
STANDARD_DEVIATION 9 • n=99 Participants
|
119 mmHg
STANDARD_DEVIATION 9 • n=107 Participants
|
120 mmHg
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Diastolic blood pressure
|
69 mmHg
STANDARD_DEVIATION 6 • n=99 Participants
|
69 mmHg
STANDARD_DEVIATION 6 • n=107 Participants
|
69 mmHg
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Pulse
|
79 beats per minute
STANDARD_DEVIATION 13 • n=99 Participants
|
80 beats per minute
STANDARD_DEVIATION 13 • n=107 Participants
|
79 beats per minute
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Breath rate
|
18 breaths/minute
STANDARD_DEVIATION 3 • n=99 Participants
|
19 breaths/minute
STANDARD_DEVIATION 4 • n=107 Participants
|
19 breaths/minute
STANDARD_DEVIATION 3 • n=206 Participants
|
|
Hemoglobin
|
14.5 g/dL
STANDARD_DEVIATION 1.1 • n=99 Participants
|
14.0 g/dL
STANDARD_DEVIATION 1.2 • n=107 Participants
|
14.2 g/dL
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Hematocrit
|
43.2 percentage of hematocrit
STANDARD_DEVIATION 3.3 • n=99 Participants
|
42.0 percentage of hematocrit
STANDARD_DEVIATION 3.4 • n=107 Participants
|
42.6 percentage of hematocrit
STANDARD_DEVIATION 3.4 • n=206 Participants
|
|
MCV
|
84.9 fL
STANDARD_DEVIATION 4.4 • n=99 Participants
|
84.7 fL
STANDARD_DEVIATION 3.4 • n=107 Participants
|
84.8 fL
STANDARD_DEVIATION 4.0 • n=206 Participants
|
|
White blood cell count (WBC)
|
7.2 10^3 cells/uL
STANDARD_DEVIATION 1.5 • n=99 Participants
|
8.6 10^3 cells/uL
STANDARD_DEVIATION 2.4 • n=107 Participants
|
7.9 10^3 cells/uL
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
Red blood cell count (RBC)
|
509 million cells/uL
STANDARD_DEVIATION 39 • n=99 Participants
|
496 million cells/uL
STANDARD_DEVIATION 37 • n=107 Participants
|
503 million cells/uL
STANDARD_DEVIATION 39 • n=206 Participants
|
|
Neutrophils
|
3541 cells/uL
STANDARD_DEVIATION 1123 • n=99 Participants
|
4231 cells/uL
STANDARD_DEVIATION 1867 • n=107 Participants
|
3869 cells/uL
STANDARD_DEVIATION 1552 • n=206 Participants
|
|
Lymphocytes
|
2656 cells/uL
STANDARD_DEVIATION 727 • n=99 Participants
|
3031 cells/uL
STANDARD_DEVIATION 1003 • n=107 Participants
|
2835 cells/uL
STANDARD_DEVIATION 884 • n=206 Participants
|
|
Monocytes
|
501 cells/uL
STANDARD_DEVIATION 165 • n=99 Participants
|
578 cells/uL
STANDARD_DEVIATION 217 • n=107 Participants
|
537 cells/uL
STANDARD_DEVIATION 194 • n=206 Participants
|
|
Eosinophils
|
297 cells/uL
STANDARD_DEVIATION 245 • n=99 Participants
|
278 cells/uL
STANDARD_DEVIATION 249 • n=107 Participants
|
288 cells/uL
STANDARD_DEVIATION 245 • n=206 Participants
|
|
Basophils
|
35 cells/uL
STANDARD_DEVIATION 37 • n=99 Participants
|
65 cells/uL
STANDARD_DEVIATION 126 • n=107 Participants
|
49 cells/uL
STANDARD_DEVIATION 91 • n=206 Participants
|
|
Platelet
|
277 1000 cells/mm^3
STANDARD_DEVIATION 57 • n=99 Participants
|
311 1000 cells/mm^3
STANDARD_DEVIATION 66 • n=107 Participants
|
293 1000 cells/mm^3
STANDARD_DEVIATION 64 • n=206 Participants
|
|
Sodium
|
140.0 mEq/L
STANDARD_DEVIATION 2.0 • n=99 Participants
|
139.7 mEq/L
STANDARD_DEVIATION 2.0 • n=107 Participants
|
139.9 mEq/L
STANDARD_DEVIATION 2.0 • n=206 Participants
|
|
Potassium
|
4.1 mEq/L
STANDARD_DEVIATION 0.3 • n=99 Participants
|
4.2 mEq/L
STANDARD_DEVIATION 0.2 • n=107 Participants
|
4.2 mEq/L
STANDARD_DEVIATION 0.3 • n=206 Participants
|
|
Chloride
|
103.9 mEq/L
STANDARD_DEVIATION 2.7 • n=99 Participants
|
102.9 mEq/L
STANDARD_DEVIATION 2.5 • n=107 Participants
|
103.4 mEq/L
STANDARD_DEVIATION 2.6 • n=206 Participants
|
|
Bicarbonate
|
24.3 mEq/L
STANDARD_DEVIATION 2.5 • n=99 Participants
|
24.7 mEq/L
STANDARD_DEVIATION 2.0 • n=107 Participants
|
24.4 mEq/L
STANDARD_DEVIATION 2.3 • n=206 Participants
|
|
Calcium
|
9.8 mEq/L
STANDARD_DEVIATION 0.4 • n=99 Participants
|
9.8 mEq/L
STANDARD_DEVIATION 0.3 • n=107 Participants
|
9.8 mEq/L
STANDARD_DEVIATION 0.3 • n=206 Participants
|
|
Blood urea nitrogen
|
10.9 mg/dL
STANDARD_DEVIATION 3.1 • n=99 Participants
|
10.5 mg/dL
STANDARD_DEVIATION 2.5 • n=107 Participants
|
10.7 mg/dL
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
Creatinine
|
0.56 mg/dL
STANDARD_DEVIATION 0.14 • n=99 Participants
|
0.56 mg/dL
STANDARD_DEVIATION 0.13 • n=107 Participants
|
0.56 mg/dL
STANDARD_DEVIATION 0.14 • n=206 Participants
|
|
Estimated glomerular filtration rate (eGFR)
|
156 mL/min/1.73m^2
STANDARD_DEVIATION 19 • n=99 Participants
|
155 mL/min/1.73m^2
STANDARD_DEVIATION 17 • n=107 Participants
|
156 mL/min/1.73m^2
STANDARD_DEVIATION 18 • n=206 Participants
|
|
Prothrombin time
|
12.3 seconds
STANDARD_DEVIATION 1.3 • n=99 Participants
|
11.9 seconds
STANDARD_DEVIATION 1.3 • n=107 Participants
|
12.1 seconds
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
International normalized ratio (INR)
|
1.04 ratio
STANDARD_DEVIATION 0.07 • n=99 Participants
|
1.04 ratio
STANDARD_DEVIATION 0.08 • n=107 Participants
|
1.04 ratio
STANDARD_DEVIATION 0.07 • n=206 Participants
|
|
Uric acid
|
6.6 mg/dL
STANDARD_DEVIATION 1.7 • n=99 Participants
|
6.6 mg/dL
STANDARD_DEVIATION 1.5 • n=107 Participants
|
6.6 mg/dL
STANDARD_DEVIATION 1.6 • n=206 Participants
|
|
C-reactive protein
|
3.8 mg/L
STANDARD_DEVIATION 2.5 • n=99 Participants
|
3.8 mg/L
STANDARD_DEVIATION 3.0 • n=107 Participants
|
3.8 mg/L
STANDARD_DEVIATION 2.7 • n=206 Participants
|
|
Time from liver biopsy
|
0.7 years
STANDARD_DEVIATION 0.6 • n=99 Participants
|
0.8 years
STANDARD_DEVIATION 0.6 • n=107 Participants
|
0.8 years
STANDARD_DEVIATION 0.6 • n=206 Participants
|
|
Nonalcoholic fatty liver disease (NAFLD) activity score
|
4.6 units on a scale
STANDARD_DEVIATION 1.5 • n=99 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
Steatohepatitis Diagnosis
NAFLD, not NASH
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Steatohepatitis Diagnosis
Borderline Zone 3
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Steatohepatitis Diagnosis
Borderline Zone 1
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Steatohepatitis Diagnosis
Definite steatohepatitis
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Fibrosis stage
Stage 0
|
17 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Fibrosis stage
Stage 1
|
13 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Fibrosis stage
Stage 2
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Fibrosis stage
Stage 3
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Hepatocellular ballooning grade
0 - None
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Hepatocellular ballooning grade
1 - Few
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Hepatocellular ballooning grade
2 - Many
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Steatosis
5-33%
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Steatosis
34-66%
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Steatosis
>66%
|
26 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Lobular inflammation
<2 under 20x magnification
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Lobular inflammation
2-4 under 20x magnification
|
16 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Lobular inflammation
>4 under 20x magnification
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Portal inflammation
None
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Portal inflammation
Mild
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Portal inflammation
More than mild
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: Results based on complete case analysis.
Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Serum Alanine Aminotransferase (ALT) From Baseline.
|
-5.3 U/L
Standard Deviation 51.4
|
-6.3 U/L
Standard Deviation 77.5
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in gamma-glutamyl transpeptidase (GGT), measured in U/L.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline
|
-1.9 U/L
Standard Deviation 13.9
|
0.6 U/L
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in serum aspartate aminotransferase, measured in U/L.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST
|
0.2 U/L
Standard Deviation 27.2
|
-4.5 U/L
Standard Deviation 37.0
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksRelative change from baseline in serum ALT, measured in percentage of change.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT
|
2.7 percentage of change
Standard Deviation 43.8
|
-5.7 percentage of change
Standard Deviation 73.2
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange from baseline in ALT at 12 weeks, measured in U/L.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in ALT at 12 Weeks Compared to Baseline ALT
|
-5.8 mg/dL
Standard Deviation 43.0
|
-19.3 mg/dL
Standard Deviation 38.5
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksHomeostasis Model Assessment of Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (umol/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline.
|
4.5 mg/dL x uU/mL/405
Standard Deviation 8.1
|
1.1 mg/dL x uU/mL/405
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in weight, measured in kg.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Weight at 24 Weeks Compared to Baseline
|
4.4 kg
Standard Deviation 4.2
|
3.9 kg
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in BMI, measured in kg/m\^2.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline.
|
0.8 kg/m^2
Standard Deviation 1.2
|
0.8 kg/m^2
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in waist circumference, measured in centimeters.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Waist Circumference at 24 Weeks Compared to Baseline
|
2.6 cm
Standard Deviation 5.4
|
0.1 cm
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in waist-to-hip ratio, measured as the circumference of the waist in centimeters divided by the circumference of the hips in centimeters.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline
|
0.01 ratio
Standard Deviation 0.05
|
-0.01 ratio
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. The outcome is 24-week change from baseline in PedsQOL Physical Health Score, where higher values indicate improvement in quality of life.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Pediatric Quality of Life Inventory (PedsQOL) Physical Health Score at 24 Weeks Compared to Baseline
|
0.9 score on a scale
Standard Deviation 14.7
|
-2.2 score on a scale
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksNumbers of adverse events reported over 24 weeks.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Frequency of Adverse Events Over 24 Weeks
|
44 adverse events
|
55 adverse events
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in total cholesterol, measured in mg/dL
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Total Cholesterol at 24 Weeks Compared to Baseline
|
-6.7 mg/dL
Standard Deviation 28.4
|
-4.1 mg/dL
Standard Deviation 25.2
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in triglycerides, measured in mg/dL
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Triglycerides at 24 Weeks Compared to Baseline
|
13.2 mg/dL
Standard Deviation 98.1
|
6.2 mg/dL
Standard Deviation 41.1
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in HDL cholesterol, measured in mg/dL
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in HDL Cholesterol at 24 Weeks Compared to Baseline
|
-2.1 mg/dL
Standard Deviation 6.2
|
-1.1 mg/dL
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange from baseline in LDL cholesterol, measured in mg/dL
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in LDL Cholesterol at 24 Weeks Compared to Baseline
|
-6.7 mg/dL
Standard Deviation 29.2
|
-6.2 mg/dL
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales. The outcome is 24-week change from baseline in PedsQOL Psychosocial Health Score, where higher values indicate improvement in quality of life.
Outcome measures
| Measure |
Losartan Potassium Capsule
n=33 Participants
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
|
Placebo Losartan Capsule
n=34 Participants
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule: Matching placebo losartan oral capsule
|
|---|---|---|
|
Change in Pediatric Quality of Life Inventory (PedsQOL) Psychosocial Health Score at 24 Weeks Compared to Baseline
|
2.7 score on a scale
Standard Deviation 12.2
|
-0.2 score on a scale
Standard Deviation 13.9
|
Adverse Events
Losartan
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Losartan
n=43 participants at risk
100 mg losartan once per day
|
Placebo
n=40 participants at risk
Matching placebo, taken once per day
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Infections and infestations
Wound infection
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Surgical and medical procedures
Surgical and medication procedures - Other, bilateral knee surgery
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
Other adverse events
| Measure |
Losartan
n=43 participants at risk
100 mg losartan once per day
|
Placebo
n=40 participants at risk
Matching placebo, taken once per day
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
5.0%
2/40 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
|
Nervous system disorders
Dizziness
|
11.6%
5/43 • Number of events 5 • Adverse event data were collected over a time period of 36 weeks.
|
7.5%
3/40 • Number of events 4 • Adverse event data were collected over a time period of 36 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
0.00%
0/40 • Adverse event data were collected over a time period of 36 weeks.
|
|
General disorders
Fatigue
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
0.00%
0/40 • Adverse event data were collected over a time period of 36 weeks.
|
|
General disorders
Fever
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Flu like symptoms
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
0.00%
0/40 • Adverse event data were collected over a time period of 36 weeks.
|
|
Nervous system disorders
Headache
|
16.3%
7/43 • Number of events 7 • Adverse event data were collected over a time period of 36 weeks.
|
17.5%
7/40 • Number of events 7 • Adverse event data were collected over a time period of 36 weeks.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
5.0%
2/40 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
|
Cardiac disorders
Hypotension
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
0.00%
0/40 • Adverse event data were collected over a time period of 36 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder, other - knee injury, pain, bursitis
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
0.00%
0/40 • Adverse event data were collected over a time period of 36 weeks.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
0.00%
0/40 • Adverse event data were collected over a time period of 36 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder, other-slipped capital femoral epiphysis (SCFE)
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
3/43 • Number of events 3 • Adverse event data were collected over a time period of 36 weeks.
|
12.5%
5/40 • Number of events 5 • Adverse event data were collected over a time period of 36 weeks.
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Rhinoseptoplasty
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
0.00%
0/40 • Adverse event data were collected over a time period of 36 weeks.
|
|
Infections and infestations
Rash, pustular
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Infections and infestations
Sinusitus
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Infections and infestations
Sore throat
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Gastrointestinal disorders
Stomach pain
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.7%
2/43 • Number of events 2 • Adverse event data were collected over a time period of 36 weeks.
|
17.5%
7/40 • Number of events 9 • Adverse event data were collected over a time period of 36 weeks.
|
|
Infections and infestations
Viremia
|
0.00%
0/43 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/43 • Number of events 1 • Adverse event data were collected over a time period of 36 weeks.
|
0.00%
0/40 • Adverse event data were collected over a time period of 36 weeks.
|
Additional Information
Laura Wilson
Johns Hopkins Bloomberg School of Public Health
Phone: 410-955-0719
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place