Hypertension
Conditions
Keywords
Children, pediatrics, High Blood Pressure, Hypertension, Valsartan
Brief summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
Interventions
DRUGValsartan
Extemporaneous suspension of valsartan, orally.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Participants who qualified and entered the core study. * Participants who participated in the core study, completed Period 1 and were re-randomized in Period 2 and continued for at least 3 days in Period 2.
Exclusion criteria
* Participants who did not complete Period 1 of the core study. * Participants who were re-randomized in Period 2 of core study but did not continue for =\> 3 days in Period 2 of the core study. * Participants who experienced any adverse events considered serious or drug related in the core study. * Participants excluded from the core study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline to Week 26 | 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. |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline to Week 26 | 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. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Week 8 to Week 26 of Extension Phase | 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. |
Countries
Belgium, Brazil, France, Hungary, India, Italy, Poland, South Africa, Turkey (Türkiye), United States
Participant flow
Recruitment details
The study was conducted at 35 investigative sites in 10 countries from 9 April 2007 to 25 March 2009.
Pre-assignment details
This study enrolled a total of 66 participants who completed the core study (NCT00435162).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Problems | 2 |
| Overall Study | Adverse Event | 3 |
| Overall Study | Participant's Condition No Longer Requires Study Drug | 1 |
Baseline characteristics
| Characteristic | Valsartan Open Label |
|---|---|
| Age, Continuous | 3.4 years STANDARD_DEVIATION 1.41 |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 66 |
| other Total, other adverse events | 38 / 66 |
| serious Total, serious adverse events | 4 / 66 |
Outcome results
Primary
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
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.
Time frame: Baseline to Week 26
Population: The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Valsartan Open Label | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline | 70.7 mmHg | Standard Deviation 11.14 |
| Valsartan Open Label | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Change from Baseline at Week 26 | -6.6 mmHg | Standard Deviation 11.84 |
Primary
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
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.
Time frame: Baseline to Week 26
Population: The extension set (ESET) included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Valsartan Open Label | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline | 114.7 millimeters of mercury (mmHg) | Standard Deviation 9.04 |
| Valsartan Open Label | 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
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Week 8 to Week 26 of Extension Phase
Population: The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valsartan Open Label | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 Participants |
| Valsartan Open Label | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 38 Participants |