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The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD patients: Valsartan+enalapril | Experimental |
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| CKD patients: Enalapril | Active Comparator |
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| Non-CKD patients: Valsartan | Experimental |
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| Non-CKD patients: Enalapril | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan | Drug | Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events | Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26 | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| 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 | CKD Patients: Valsartan+Enalapril | Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Enalapril | Drug | Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
|
| placebo matched to enalapril | Drug | Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
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| placebo matched to valsartan | Drug | placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
|
| Core Baseline (Week 0) to Week 26 |
| Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26 | Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP < 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. | Week 26 |
| Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20 | 24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm. | Core Baseline (Week 0) to Week 20 |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26 | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. | Core Baseline (Week 0) to Week 26 |
| Belgium |
| Belgium |
| Sites in France | France | France |
| Sites in Germany | Germany | Germany |
| Sites in Hungary | Hungary | Hungary |
| Sites in India | India | India |
| Sites in Italy | Italy | Italy |
| Sites in Poland | Poland | Poland |
| Sites in Turkey | Turkey | Turkey (Türkiye) |
| FG001 |
| CKD Patients: Enalapril |
Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| FG002 | Non-CKD Patients: Valsartan | Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| FG003 | Non-CKD Patients: Enalapril | Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CKD Patients: Valsartan+Enalapril | Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| BG001 | CKD Patients: Enalapril | Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| BG002 | Non-CKD Patients: Valsartan | Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| BG003 | Non-CKD Patients: Enalapril | Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| BG004 | 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 |
| |||||||||||||||
| 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 | Number of Patients With Adverse Events | Extension safety population | Posted | Number | Participants | Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients) |
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| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26 | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. | Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value. | Posted | Mean | Standard Deviation | mmHg | Core Baseline (Week 0) to Week 26 |
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| Secondary | Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26 | Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP < 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. | The extension ITT population consisted of all extension patients that had both baseline and at least one post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic blood pressure) during the extension. Patients were analyzed according to the treatment they were assigned to at the beginning of their extension. | Posted | Number | Percentage of patients | Week 26 |
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| Secondary | Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20 | 24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm. | ABPM population: All ITT patients who received the 24-hour ambulatory blood pressure monitoring (ABPM) measurements at both baseline and Week 20. Patients were excluded if their baseline ABPM was measured after active treatment dose (considered invalid baseline). | Posted | Mean | Standard Deviation | mmHg | Core Baseline (Week 0) to Week 20 |
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| Secondary | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26 | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. | Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value. | Posted | Mean | Standard Deviation | mmHg | Core Baseline (Week 0) to Week 26 |
|
Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients).
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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 | CKD Patients: Valsartan+Enalapril | Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. | 7 | 21 | 14 | 21 | ||
| EG001 | Non-CKD Patients: Valsartan | Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. | 1 | 103 | 25 | 103 | ||
| EG002 | CKD Patients: Enalapril | Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food. | 0 | 17 | 11 | 17 | ||
| EG003 | Non-CKD Patients: Enalapril | Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. | 2 | 109 | 42 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenogenital syndrome | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
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| Kidney transplant rejection | Immune system disorders | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Synostosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Epilepsy | Nervous system disorders | 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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| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
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Study was prolonged from 14 to 66 wks for CKD patients only. Most CKD patients completed the initial 14 wk extension period prior to amendment approval and the study was terminated prematurely with 3 CKD patients progressing to a maximum of Visit 13.
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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| Male |
|
| OG002 | Non-CKD Patients: Valsartan | Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| OG003 | Non-CKD Patients: Enalapril | Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
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| OG002 | Non-CKD Patients: Valsartan | Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| OG003 | Non-CKD Patients: Enalapril | Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
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| OG002 | Non-CKD Patients: Valsartan | Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
| OG003 | Non-CKD Patients: Enalapril | Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food. |
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