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The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan 80 mg | Experimental |
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| Valsartan 160 mg | Experimental |
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| Valsartan 320 mg | Experimental |
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| Enalapril 10 mg | Active Comparator |
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| Enalapril 20 mg | Active Comparator |
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| Enalapril 40 mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan | Drug | Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure. | Baseline and Week 12 |
| Decrease in MSSBP to < 95th Percentile for Age, Gender and Height |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sites in USA | East Hanover | New Jersey | 07936 | United States | ||
| Sites in Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valsartan | Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg. |
| FG001 | Enalapril | Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Enalapril | Drug | Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg. |
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The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12. |
| at week 12 |
| Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients | The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients. | Baseline and Week 8 |
| Sites in Belgium |
| Belgium |
| Sites in France | Sites in France | France |
| Sites in Germany | Sites in Germany | Germany |
| Sites in Hungary | Hungary | Hungary |
| Sites in India | Sites in India | India |
| Sites in Italy | Sites in Italy | Italy |
| Sites in Poland | Poland | Poland |
| Sites in Slovakia | Slovakia | Slovakia |
| Sites in Sweden | Sites in Sweden | 00000 | Sweden |
| Sites in Turkey | Turkey | Turkey (Türkiye) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Valsartan | Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg. |
| BG001 | Enalapril | Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement. | Intent-to-treat. Only patients who had both baseline and endpoint values are included. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 12 |
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| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure. | Intent-to-treat. Only patients who had both baseline and endpoint values are included. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 12 |
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| Secondary | Decrease in MSSBP to < 95th Percentile for Age, Gender and Height | The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12. | Intent-to-treat. Only patients who had both baseline and endpoint values are included. | Posted | Number | Percentage of participants | at week 12 |
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| Secondary | Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients | The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients. | A subset of approximately 100 - 150 patients from selected centers was expected to undergo Ambulatory Blood Pressure Monitoring at baseline (Week 0) and at Week 8; however, only 56 patients chose to participate in this aspect of the study. | Posted | Mean | Standard Deviation | mm Hg | Baseline and Week 8 |
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Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
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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 | Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg. | 3 | 151 | 42 | 151 | ||
| EG001 | Enalapril | Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg. | 2 | 148 | 52 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Renal injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Brain injury | Nervous system disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | 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 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D004656 | Enalapril |
| 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 |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
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