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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017029-20 | EudraCT Number |
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The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren | Experimental | Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg |
|
| Enalapril | Active Comparator | Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study | Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit. | Baseline - end of study (Week 52 or Last observation carried forward (LOCF) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study | Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit. |
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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 | Birmingham | Alabama | 35294-0006 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33089502 | Derived | Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren | Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Enalapril | Drug | Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg |
|
| Baseline - end of study (Week 52 or Last observation carried forward (LOCF) |
| Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study | MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP--DBP). | Baseline to end of study (Week 52 or LOCF) |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Novartis Investigative Site | Los Angeles | California | 90048 | United States |
| Novartis Investigative Site | Dalton | Georgia | 30721 | United States |
| Novartis Investigative Site | Lewiston | Idaho | 83501 | United States |
| Novartis Investigative Site | Park Ridge | Illinois | 60068 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40202 | United States |
| Novartis Investigative Site | Hattiesburg | Mississippi | 39401 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | United States |
| Novartis Investigative Site | New York | New York | 10016 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43205 | United States |
| Novartis Investigative Site | Toledo | Ohio | 43606 | United States |
| Novartis Investigative Site | Portland | Oregon | 07227 | United States |
| Novartis Investigative Site | Portland | Oregon | 97225 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29425 | United States |
| Novartis Investigative Site | Amarillo | Texas | 79106 | United States |
| Novartis Investigative Site | Charleston | West Virginia | 25304 | United States |
| Novartis Investigative Site | Guatemala City | Departamento de Guatemala | 01010 | Guatemala |
| Novartis Investigative Site | Nyíregyháza | Hungary | 4400 | Hungary |
| Novartis Investigative Site | Szeged | Hungary | 6725 | Hungary |
| Novartis Investigative Site | Budapest | 1083 | Hungary |
| Novartis Investigative Site | Budapest | 1131 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Miskolc | 3529 | Hungary |
| Novartis Investigative Site | Veszprém | H-8200 | Hungary |
| Novartis Investigative Site | Warsaw | 04-154 | Poland |
| Novartis Investigative Site | San Juan | 00907 | Puerto Rico |
| Novartis Investigative Site | Bratislava | Slovakia | 84103 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovakia | 85107 | Slovakia |
| Novartis Investigative Site | Martin | Slovakia | 03601 | Slovakia |
| Novartis Investigative Site | Myjava | Slovakia | 90701 | Slovakia |
| Novartis Investigative Site | Prešov | Slovakia | 08001 | Slovakia |
| Novartis Investigative Site | Trnava | Slovakia | 91701 | Slovakia |
| Novartis Investigative Site | Ankara | Turkey | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Turkey | 06490 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Turkey | 06500 | Turkey (Türkiye) |
| FG001 | Enalapril | Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg |
| Safety Set (SAF) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren | Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg |
| BG001 | Enalapril | Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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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| Age, Customized | Number | participants |
| ||||||||||||||||
| 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) at to End of Study | Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit. | Full analysis set (FAS) included all randomized patients for this trial | Posted | Least Squares Mean | Standard Error | millimeter(s) of mercury (mmHg) | Baseline - end of study (Week 52 or Last observation carried forward (LOCF) |
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| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study | Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit. | Full analysis set (FAS) included all randomized patients for this trial | Posted | Least Squares Mean | Standard Error | mmHg | Baseline - end of study (Week 52 or Last observation carried forward (LOCF) |
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| Secondary | Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study | MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP--DBP). | Full analysis set (FAS) included all randomized patients for this trial | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to end of study (Week 52 or LOCF) |
|
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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 | Aliskiren | Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg | 3 | 105 | 52 | 105 | ||
| EG001 | Enalapril | Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg | 12 | 103 | 51 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Skull fractured base | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA | Systematic Assessment |
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| Tetany | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Psychosomatic disease | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Bronchitis | Infections and infestations | 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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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral 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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| Oropharyngeal pain | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 -778 -8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D004656 | Enalapril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Adolescents 12 - 17 years |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
|
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