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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005473-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan Open Label | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan | Drug | Extemporaneous suspension of valsartan, orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 26 |
| 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. | Baseline to Week 26 |
| 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. | Week 8 to Week 26 of Extension Phase |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hackensack | New Jersey | 07601 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23511339 | Result | Schaefer F, Coppo R, Bagga A, Senguttuvan P, Schlosshauer R, Zhang Y, Kadwa M. Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age. J Hypertens. 2013 May;31(5):993-1000. doi: 10.1097/HJH.0b013e32835f5721. |
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This study enrolled a total of 66 participants who completed the core study (NCT00435162).
The study was conducted at 35 investigative sites in 10 countries from 9 April 2007 to 25 March 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Novartis Investigative Site | Norfolk | Virginia | 23510 | United States |
| Novartis Investigative Site | Antwerp | 2020 | Belgium |
| Novartis Investigative Site | Edegem | 2650 | Belgium |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Laken | 1020 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Goiânia | Goiás | 74605-050 | Brazil |
| Novartis Investigative Site | Curitiba | Paraná | 80250-030 | Brazil |
| Novartis Investigative Site | Recife | Pernambuco | 50070-050 | Brazil |
| Novartis Investigative Site | Marseille | 13385 | France |
| Novartis Investigative Site | Paris | 75935 | France |
| Novartis Investigative Site | Toulouse | 31026 | France |
| Novartis Investigative Site | Budapest | H-1083 | Hungary |
| Novartis Investigative Site | Szeged | H-6720 | Hungary |
| Novartis Investigative Site | Hyderabad | Andh Prad | 500033 | India |
| Novartis Investigative Site | Mangalore | Karnataka | 575001 | India |
| Novartis Investigative Site | Indore | M.P. | 425001 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 400026 | India |
| Novartis Investigative Site | Chennai | Tamil Nadu | 600008 | India |
| Novartis Investigative Site | New Delhi | 110 029 | India |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Palermo | 90134 | Italy |
| Novartis Investigative Site | Gdansk | 80-952 | Poland |
| Novartis Investigative Site | Krakow | 30-663 | Poland |
| Novartis Investigative Site | Lodz | 93-338 | Poland |
| Novartis Investigative Site | Poznan | 60-572 | Poland |
| Novartis Investigative Site | Szczecin | 70-410 | Poland |
| Novartis Investigative Site | Warsaw | 04-730 | Poland |
| Novartis Investigative Site | Gezina | Gauteng | 0084 | South Africa |
| Novartis Investigative Site | Cape Town | 7505 | South Africa |
| Novartis Investigative Site | Potchefstroom | South Africa |
| Novartis Investigative Site | Pretoria | 0002 | South Africa |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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Enrolled extension participants (ENRE) included all participants who were enrolled into this extension study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The extension set (ESET) included all participants who entered the extension study, with administration of at least one dose of open-label study drug. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline to Week 26 |
|
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| ||||||||||||||||||||||||||||||||
| 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. | The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug. | Posted | Mean | Standard Deviation | mmHg | Baseline to Week 26 |
|
| |||||||||||||||||||||||||||||||||
| 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. | The ESET included all participants who entered the extension study, with administration of at least one dose of open-label study drug. | Posted | Count of Participants | Participants | Week 8 to Week 26 of Extension Phase |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 MSSBP control after 2 weeks up to 18 weeks. | 0 | 66 | 4 | 66 | 38 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Varicella | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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