Trial Outcomes & Findings for Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure (NCT NCT00435162)
NCT ID: NCT00435162
Last Updated: 2011-05-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
baseline and week 6
Results posted on
2011-05-09
Participant Flow
At period 1, participants were randomized (2:1:2) to Valsartan 0.25 mg/kg, 1.0 mg/kg or 4.0 mg/kg. At period 2, participants were randomized (1:1) to either stay on Valsartan or switch to placebo.
Participant milestones
| Measure |
Low Dose in Both Periods
Valsartan 0.25 mg/kg in both periods
|
Low Dose, Then Placebo
Valsartan 0.25 mg/kg, then placebo
|
Medium Dose in Both Periods
Valsartan 1.0 mg/kg in both periods
|
Medium Dose, Then Placebo
Valsartan 1.0 mg/kg, then placebo
|
High Dose in Both Periods
Valsartan 1.0 mg/kg, then placebo
|
High Dose, Then Placebo
Valsartan 4.0 mg/kg, then placebo
|
|---|---|---|---|---|---|---|
|
Period 1 (6 Weeks)
STARTED
|
15
|
15
|
6
|
8
|
15
|
15
|
|
Period 1 (6 Weeks)
COMPLETED
|
15
|
15
|
6
|
8
|
15
|
15
|
|
Period 1 (6 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (2 Weeks)
STARTED
|
15
|
15
|
6
|
8
|
15
|
15
|
|
Period 2 (2 Weeks)
COMPLETED
|
15
|
14
|
6
|
8
|
15
|
15
|
|
Period 2 (2 Weeks)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Low Dose in Both Periods
Valsartan 0.25 mg/kg in both periods
|
Low Dose, Then Placebo
Valsartan 0.25 mg/kg, then placebo
|
Medium Dose in Both Periods
Valsartan 1.0 mg/kg in both periods
|
Medium Dose, Then Placebo
Valsartan 1.0 mg/kg, then placebo
|
High Dose in Both Periods
Valsartan 1.0 mg/kg, then placebo
|
High Dose, Then Placebo
Valsartan 4.0 mg/kg, then placebo
|
|---|---|---|---|---|---|---|
|
Period 2 (2 Weeks)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Baseline characteristics by cohort
| Measure |
Low Dose
n=30 Participants
Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
|
Medium Dose
n=14 Participants
Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
|
High Dose
n=30 Participants
Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
3.4 years
STANDARD_DEVIATION 1.28 • n=5 Participants
|
3.2 years
STANDARD_DEVIATION 1.48 • n=7 Participants
|
3.3 years
STANDARD_DEVIATION 1.53 • n=5 Participants
|
3.3 years
STANDARD_DEVIATION 1.41 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and week 6Population: Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)
Outcome measures
| Measure |
Low Dose
n=30 Participants
Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
|
Medium Dose
n=14 Participants
Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
|
High Dose
n=30 Participants
Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
|
|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
|
-8.3 mm Hg
Standard Deviation 10.44
|
-10.3 mm Hg
Standard Deviation 9.83
|
-14.4 mm Hg
Standard Deviation 10.93
|
SECONDARY outcome
Timeframe: baseline and week 6Population: Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)
Outcome measures
| Measure |
Low Dose
n=30 Participants
Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
|
Medium Dose
n=14 Participants
Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
|
High Dose
n=30 Participants
Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
|
|---|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)
|
-4.7 mm Hg
Standard Deviation 9.53
|
-8.6 mm Hg
Standard Deviation 12.43
|
-6.7 mm Hg
Standard Deviation 10.61
|
SECONDARY outcome
Timeframe: week 6 and week 8Population: Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)
Outcome measures
| Measure |
Low Dose
n=35 Participants
Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
|
Medium Dose
n=38 Participants
Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
|
High Dose
Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
|
|---|---|---|---|
|
Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)
|
2.6 mm Hg
Standard Deviation 8.38
|
4.1 mm Hg
Standard Deviation 9.66
|
—
|
SECONDARY outcome
Timeframe: week 6 and week 8Population: Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)
Outcome measures
| Measure |
Low Dose
n=35 Participants
Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
|
Medium Dose
n=38 Participants
Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
|
High Dose
Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
|
|---|---|---|---|
|
Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)
|
1.8 mm Hg
Standard Deviation 8.99
|
3.4 mm Hg
Standard Deviation 8.74
|
—
|
Adverse Events
Low Dose in Both Periods
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Low Dose, Then Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Medium Dose in Both Periods
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medium Dose, Then Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
High Dose in Both Periods
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
High Dose, Then Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose in Both Periods
n=15 participants at risk
Valsartan 0.25 mg/kg in both periods
|
Low Dose, Then Placebo
n=15 participants at risk
Valsartan 0.25 mg/kg, then Placebo
|
Medium Dose in Both Periods
n=6 participants at risk
Valsartan 1.0 mg/kg in both periods
|
Medium Dose, Then Placebo
n=8 participants at risk
Valsartan 1.0 mg/kg, then Placebo
|
High Dose in Both Periods
n=15 participants at risk
Valsartan 4.0 mg/kg in both periods
|
High Dose, Then Placebo
n=15 participants at risk
Valsartan 4.0 mg/kg, then Placebo
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Renal and urinary disorders
Nephrotic syndrome
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
12.5%
1/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
Other adverse events
| Measure |
Low Dose in Both Periods
n=15 participants at risk
Valsartan 0.25 mg/kg in both periods
|
Low Dose, Then Placebo
n=15 participants at risk
Valsartan 0.25 mg/kg, then Placebo
|
Medium Dose in Both Periods
n=6 participants at risk
Valsartan 1.0 mg/kg in both periods
|
Medium Dose, Then Placebo
n=8 participants at risk
Valsartan 1.0 mg/kg, then Placebo
|
High Dose in Both Periods
n=15 participants at risk
Valsartan 4.0 mg/kg in both periods
|
High Dose, Then Placebo
n=15 participants at risk
Valsartan 4.0 mg/kg, then Placebo
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
12.5%
1/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
16.7%
1/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
16.7%
1/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
20.0%
3/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
12.5%
1/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
12.5%
1/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Impetigo
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
16.7%
1/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
12.5%
1/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Tonsillitis
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
20.0%
3/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Infections and infestations
Varicella
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
12.5%
1/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
12.5%
1/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
13.3%
2/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
12.5%
1/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/6 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/8 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
0.00%
0/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
6.7%
1/15 • Period 1 (Baseline to Week 6) and Period 2 (Week 6 to Week 8)
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER