Trial Outcomes & Findings for A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension (NCT NCT00457626)
NCT ID: NCT00457626
Last Updated: 2021-09-05
Results Overview
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
COMPLETED
PHASE3
66 participants
Baseline to Week 26
2021-09-05
Participant Flow
The study was conducted at 35 investigative sites in 10 countries from 9 April 2007 to 25 March 2009.
This study enrolled a total of 66 participants who completed the core study (NCT00435162).
Participant milestones
| Measure |
Valsartan Open Label
Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
|
|---|---|
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Overall Study
STARTED
|
66
|
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Overall Study
COMPLETED
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60
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Valsartan Open Label
Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
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|---|---|
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Overall Study
Adverse Event
|
3
|
|
Overall Study
Administrative Problems
|
2
|
|
Overall Study
Participant's Condition No Longer Requires Study Drug
|
1
|
Baseline Characteristics
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
Baseline characteristics by cohort
| Measure |
Valsartan Open Label
n=66 Participants
Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
|
|---|---|
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Age, Continuous
|
3.4 years
STANDARD_DEVIATION 1.41 • n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: The extension set (ESET) included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Valsartan Open Label
n=66 Participants
Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
|
|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Baseline
|
114.7 millimeters of mercury (mmHg)
Standard Deviation 9.04
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Change from Baseline at Week 26
|
-11.2 millimeters of mercury (mmHg)
Standard Deviation 12.56
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three SDBP measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Valsartan Open Label
n=66 Participants
Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
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|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Baseline
|
70.7 mmHg
Standard Deviation 11.14
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Change from Baseline at Week 26
|
-6.6 mmHg
Standard Deviation 11.84
|
PRIMARY outcome
Timeframe: Week 8 to Week 26 of Extension PhasePopulation: The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Outcome measures
| Measure |
Valsartan Open Label
n=66 Participants
Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
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|---|---|
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
38 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
4 Participants
|
Adverse Events
Valsartan Open Label
Serious adverse events
| Measure |
Valsartan Open Label
n=66 participants at risk
Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
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|---|---|
|
Infections and infestations
Viral infection
|
1.5%
1/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
1/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.5%
1/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
1.5%
1/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.5%
1/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
Other adverse events
| Measure |
Valsartan Open Label
n=66 participants at risk
Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg escalated to 2 mg/kg or 4 mg/kg based on MSSBP control after 2 weeks up to 18 weeks.
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|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
3/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
2/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
3/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
General disorders
Pyrexia
|
16.7%
11/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Bronchitis
|
7.6%
5/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Ear infection
|
4.5%
3/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
7/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Pharyngitis
|
4.5%
3/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Rhinitis
|
4.5%
3/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Tonsillitis
|
3.0%
2/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.6%
5/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
2/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Varicella
|
3.0%
2/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Infections and infestations
Viral infection
|
6.1%
4/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.0%
2/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Nervous system disorders
Headache
|
4.5%
3/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
4/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.0%
2/66 • Week 8 to Week 26 of Extension Phase
The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
|
Additional Information
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