Trial Outcomes & Findings for Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age (NCT NCT01365481)
NCT ID: NCT01365481
Last Updated: 2016-07-13
Results Overview
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Results posted on
2016-07-13
Participant Flow
A 1 arm study of valsartan but with 2 groups for analyses. The valsartan +antihypertensive group includes the patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
These 2 groups were not randomized and considered to be 2 different populations since the patients in the valsartan+antihypertensive group had concomitant antihypertensive usage per individual patient's conditions at any time during treatment period.
Participant milestones
| Measure |
CKD Patients: Valsartan + Antihypertensive Group
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
CKD Patients: Valsartan Alone
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
Non-CKD Patients: Valsartan + Antihypertensive Group
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Non-CKD Patients: Valsartan Alone
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
52
|
18
|
57
|
|
Overall Study
COMPLETED
|
16
|
37
|
14
|
50
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
4
|
7
|
Reasons for withdrawal
| Measure |
CKD Patients: Valsartan + Antihypertensive Group
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
CKD Patients: Valsartan Alone
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
Non-CKD Patients: Valsartan + Antihypertensive Group
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Non-CKD Patients: Valsartan Alone
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
9
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
3
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
1
|
0
|
0
|
|
Overall Study
Administrative problems
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol deviation
|
0
|
1
|
0
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
Baseline characteristics by cohort
| Measure |
CKD Patients: Valsartan + Antihypertensive Group
n=23 Participants
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
CKD Patients: Valsartan Alone
n=52 Participants
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
Non-CKD Patients: Valsartan + Antihypertensive Group
n=18 Participants
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Non-CKD Patients: Valsartan Alone
n=57 Participants
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
12.90 years
STANDARD_DEVIATION 3.35 • n=5 Participants
|
12.30 years
STANDARD_DEVIATION 3.20 • n=7 Participants
|
13.79 years
STANDARD_DEVIATION 2.64 • n=5 Participants
|
14.37 years
STANDARD_DEVIATION 2.83 • n=4 Participants
|
13.36 years
STANDARD_DEVIATION 3.130 • n=21 Participants
|
|
Age, Customized
6 - 11 years
|
10 participants
n=5 Participants
|
22 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
Age, Customized
12 - 17 years
|
13 participants
n=5 Participants
|
30 participants
n=7 Participants
|
15 participants
n=5 Participants
|
47 participants
n=4 Participants
|
105 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)Population: The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Valsartan + Antihypertensive Group
n=41 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Valsartan Alone
n=109 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
|
-13.3 millimeter(s) of mercury (mmHg)
Standard Deviation 13.69
|
-15.5 millimeter(s) of mercury (mmHg)
Standard Deviation 13.35
|
PRIMARY outcome
Timeframe: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)Population: The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Valsartan + Antihypertensive Group
n=41 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Valsartan Alone
n=109 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
|
-10.3 millimeter(s) of mercury (mmHg)
Standard Deviation 11.94
|
-10.8 millimeter(s) of mercury (mmHg)
Standard Deviation 11.45
|
SECONDARY outcome
Timeframe: End Point (Week 78 or Last observation carried forward (LOCF)Population: The Full Analysis set (FAS) included all patients who entered the treatment period. This analysis includes only participants with baseline MSSBP or MSDBP or (MSSBP or MSDBP combined) ≥95th percentile for gender, age and height. n analyzed is displayed in left column. This OM did not break up the analysis between CKD and non-CKD patients.
Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height
Outcome measures
| Measure |
Valsartan + Antihypertensive Group
n=41 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Valsartan Alone
n=109 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|
|
Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
MSSBP (n=39, 105)
|
23 Number of Participants
|
90 Number of Participants
|
|
Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
MSDBP (n=28, 51)
|
20 Number of Participants
|
47 Number of Participants
|
|
Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
MSSBP and MSDBP combined (n=40, 105)
|
22 Number of Participants
|
88 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)Population: The Safety set (SAF) included all patients who received at least one dose of study medication that has Chronic Kidney Disease (CKD) only
Percentage of Patients with CKD who had Urine albumin creatinine reduction \>/= 50% from baseline
Outcome measures
| Measure |
Valsartan + Antihypertensive Group
n=23 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Valsartan Alone
n=52 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|
|
Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point
|
50.0 Percentage of patients
404.08
|
41.9 Percentage of patients
138.66
|
SECONDARY outcome
Timeframe: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)Population: The Safety set (SAF) included all patients who received at least one dose of study medication.that has Chronic Kidney Disease (CKD)
Percentage of Patients with CKD who had eGFR decrease \> 25 % from Baseline
Outcome measures
| Measure |
Valsartan + Antihypertensive Group
n=23 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Valsartan Alone
n=52 Participants
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|
|
Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point
|
30.4 Percentage of patients
404.08
|
27.5 Percentage of patients
138.66
|
Adverse Events
Valsartan + Antihypertensive Group
Serious events: 8 serious events
Other events: 34 other events
Deaths: 0 deaths
Valsartan Alone
Serious events: 7 serious events
Other events: 68 other events
Deaths: 0 deaths
CKD Patients: Valsartan + Antihypertensive Group
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
CKD Patients: Valsartan Alone
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Non-CKD Patients: Valsartan + Antihypertensive Group
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Non-CKD Patients: Valsartan Alone
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valsartan + Antihypertensive Group
n=41 participants at risk
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Valsartan Alone
n=109 participants at risk
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
CKD Patients: Valsartan + Antihypertensive Group
n=23 participants at risk
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
CKD Patients: Valsartan Alone
n=52 participants at risk
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
Non-CKD Patients: Valsartan + Antihypertensive Group
n=18 participants at risk
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Non-CKD Patients: Valsartan Alone
n=57 participants at risk
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Gastrointestinal disorders
Oesophageal polyp
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
General disorders
Face oedema
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
General disorders
Oedema peripheral
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
0.00%
0/52
|
0.00%
0/18
|
1.8%
1/57
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41
|
0.92%
1/109
|
4.3%
1/23
|
1.9%
1/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
1.9%
1/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
0.00%
0/52
|
0.00%
0/18
|
1.8%
1/57
|
|
Investigations
Glomerular filtration rate decreased
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Nervous system disorders
Somnolence
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
0.00%
0/52
|
0.00%
0/18
|
1.8%
1/57
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
0.00%
0/52
|
0.00%
0/18
|
1.8%
1/57
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
1.9%
1/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Renal and urinary disorders
Lupus nephritis
|
7.3%
3/41
|
0.92%
1/109
|
13.0%
3/23
|
1.9%
1/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
1.9%
1/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
1.9%
1/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
1/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Vascular disorders
Hypertension
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Vascular disorders
Hypotension
|
0.00%
0/41
|
0.92%
1/109
|
0.00%
0/23
|
0.00%
0/52
|
0.00%
0/18
|
1.8%
1/57
|
Other adverse events
| Measure |
Valsartan + Antihypertensive Group
n=41 participants at risk
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Valsartan Alone
n=109 participants at risk
Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
CKD Patients: Valsartan + Antihypertensive Group
n=23 participants at risk
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
CKD Patients: Valsartan Alone
n=52 participants at risk
CKD Patients - Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
Non-CKD Patients: Valsartan + Antihypertensive Group
n=18 participants at risk
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Non-CKD Patients: Valsartan Alone
n=57 participants at risk
Non-CKD patients-Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Eye disorders
Myopia
|
2.4%
1/41
|
0.92%
1/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
1.8%
1/57
|
|
Eye disorders
Retinal vascular disorder
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Eye disorders
Vision blurred
|
4.9%
2/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Gastrointestinal disorders
Abdominal pain
|
9.8%
4/41
|
6.4%
7/109
|
8.7%
2/23
|
7.7%
4/52
|
11.1%
2/18
|
5.3%
3/57
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.9%
2/41
|
4.6%
5/109
|
8.7%
2/23
|
3.8%
2/52
|
0.00%
0/18
|
5.3%
3/57
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
2/41
|
7.3%
8/109
|
4.3%
1/23
|
9.6%
5/52
|
5.6%
1/18
|
5.3%
3/57
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41
|
2.8%
3/109
|
8.7%
2/23
|
3.8%
2/52
|
0.00%
0/18
|
1.8%
1/57
|
|
Gastrointestinal disorders
Toothache
|
7.3%
3/41
|
0.92%
1/109
|
8.7%
2/23
|
0.00%
0/52
|
5.6%
1/18
|
1.8%
1/57
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
5/41
|
3.7%
4/109
|
17.4%
4/23
|
5.8%
3/52
|
5.6%
1/18
|
1.8%
1/57
|
|
General disorders
Asthenia
|
4.9%
2/41
|
0.92%
1/109
|
4.3%
1/23
|
0.00%
0/52
|
5.6%
1/18
|
1.8%
1/57
|
|
General disorders
Chest pain
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
General disorders
Pyrexia
|
29.3%
12/41
|
16.5%
18/109
|
34.8%
8/23
|
23.1%
12/52
|
22.2%
4/18
|
10.5%
6/57
|
|
Infections and infestations
Acarodermatitis
|
2.4%
1/41
|
0.92%
1/109
|
0.00%
0/23
|
1.9%
1/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Infections and infestations
Enterobiasis
|
2.4%
1/41
|
0.92%
1/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
1.8%
1/57
|
|
Infections and infestations
Influenza
|
7.3%
3/41
|
0.92%
1/109
|
4.3%
1/23
|
0.00%
0/52
|
11.1%
2/18
|
1.8%
1/57
|
|
Infections and infestations
Mycoplasma infection
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Infections and infestations
Nasopharyngitis
|
26.8%
11/41
|
20.2%
22/109
|
30.4%
7/23
|
26.9%
14/52
|
22.2%
4/18
|
14.0%
8/57
|
|
Infections and infestations
Pharyngitis
|
4.9%
2/41
|
0.00%
0/109
|
8.7%
2/23
|
0.00%
0/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Infections and infestations
Respiratory tract infection
|
4.9%
2/41
|
3.7%
4/109
|
4.3%
1/23
|
0.00%
0/52
|
5.6%
1/18
|
7.0%
4/57
|
|
Infections and infestations
Rhinitis
|
0.00%
0/41
|
2.8%
3/109
|
0.00%
0/23
|
0.00%
0/52
|
0.00%
0/18
|
5.3%
3/57
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
2/41
|
15.6%
17/109
|
4.3%
1/23
|
23.1%
12/52
|
5.6%
1/18
|
8.8%
5/57
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41
|
2.8%
3/109
|
8.7%
2/23
|
3.8%
2/52
|
0.00%
0/18
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
1/41
|
3.7%
4/109
|
4.3%
1/23
|
7.7%
4/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41
|
3.7%
4/109
|
4.3%
1/23
|
5.8%
3/52
|
0.00%
0/18
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
2/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
11.1%
2/18
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41
|
0.00%
0/109
|
8.7%
2/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Nervous system disorders
Dizziness
|
19.5%
8/41
|
15.6%
17/109
|
17.4%
4/23
|
11.5%
6/52
|
22.2%
4/18
|
19.3%
11/57
|
|
Nervous system disorders
Headache
|
34.1%
14/41
|
21.1%
23/109
|
34.8%
8/23
|
21.2%
11/52
|
33.3%
6/18
|
21.1%
12/57
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
1/41
|
0.92%
1/109
|
0.00%
0/23
|
1.9%
1/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Renal and urinary disorders
Micturition urgency
|
2.4%
1/41
|
0.92%
1/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.9%
18/41
|
16.5%
18/109
|
52.2%
12/23
|
23.1%
12/52
|
33.3%
6/18
|
10.5%
6/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41
|
1.8%
2/109
|
0.00%
0/23
|
3.8%
2/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.9%
2/41
|
0.92%
1/109
|
4.3%
1/23
|
0.00%
0/52
|
5.6%
1/18
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.3%
3/41
|
0.92%
1/109
|
4.3%
1/23
|
1.9%
1/52
|
11.1%
2/18
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
2/41
|
1.8%
2/109
|
4.3%
1/23
|
1.9%
1/52
|
5.6%
1/18
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.9%
2/41
|
0.00%
0/109
|
4.3%
1/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.8%
4/41
|
2.8%
3/109
|
13.0%
3/23
|
3.8%
2/52
|
5.6%
1/18
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.4%
1/41
|
1.8%
2/109
|
0.00%
0/23
|
1.9%
1/52
|
5.6%
1/18
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Papule
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/41
|
2.8%
3/109
|
0.00%
0/23
|
5.8%
3/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Vascular disorders
Hypertension
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
|
Vascular disorders
Hypotension
|
4.9%
2/41
|
1.8%
2/109
|
8.7%
2/23
|
3.8%
2/52
|
0.00%
0/18
|
0.00%
0/57
|
|
Vascular disorders
Pallor
|
2.4%
1/41
|
0.00%
0/109
|
0.00%
0/23
|
0.00%
0/52
|
5.6%
1/18
|
0.00%
0/57
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER