Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 10:30 AM
Study NCT ID:
NCT01150357
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2010-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862 -778 -8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.', 'otherNumAtRisk': 108, 'otherNumAffected': 11, 'seriousNumAtRisk': 108, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.', 'otherNumAtRisk': 54, 'otherNumAffected': 6, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.', 'otherNumAtRisk': 105, 'otherNumAffected': 14, 'seriousNumAtRisk': 105, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Phase 2: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.', 'otherNumAtRisk': 50, 'otherNumAffected': 8, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Phase 2: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.', 'otherNumAtRisk': 30, 'otherNumAffected': 7, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Phase 2: Aliskiren High (150/300/600 mg)', 'description': 'Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and\n\n≤ 150 kg received 600 mg of aliskiren.', 'otherNumAtRisk': 50, 'otherNumAffected': 9, 'seriousNumAtRisk': 50, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Phase 2: Placebo Low', 'description': 'Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.', 'otherNumAtRisk': 57, 'otherNumAffected': 7, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Phase 2: Placebo Mid', 'description': 'Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily.', 'otherNumAtRisk': 21, 'otherNumAffected': 3, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Phase 2: Placebo High', 'description': 'Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.', 'otherNumAtRisk': 52, 'otherNumAffected': 5, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.54', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-5.42', 'spread': '1.331', 'groupId': 'OG001'}, {'value': '-9.03', 'spread': '1.008', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))', 'description': '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 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.', 'unitOfMeasure': 'millimeter(s) of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy. Here, "Number of participants analyzed" signifies participants evaluable for msSBP at Week 4 or LOCF for each arm, respectively.'}, {'type': 'PRIMARY', 'title': 'Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo Low', 'description': 'Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.'}, {'id': 'OG002', 'title': 'Phase 2: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG003', 'title': 'Phase 2: Placebo Mid', 'description': 'Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.'}, {'id': 'OG004', 'title': 'Phase 2: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}, {'id': 'OG005', 'title': 'Phase 2: Placebo High', 'description': 'Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.947', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '1.256', 'groupId': 'OG001'}, {'value': '-2.59', 'spread': '1.119', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '1.481', 'groupId': 'OG003'}, {'value': '-1.97', 'spread': '1.071', 'groupId': 'OG004'}, {'value': '1.11', 'spread': '1.185', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 to endpoint (Week 8 or LOCF)', 'description': '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 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis was performed on the FAS population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 4', 'description': 'Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Sets (SAF), SAF is all participants who received at least one dose of study treatment during phase 1 (baseline to week 4)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo Low', 'description': 'Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.'}, {'id': 'OG002', 'title': 'Phase 2: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG003', 'title': 'Phase 2: Placebo Mid', 'description': 'Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.'}, {'id': 'OG004', 'title': 'Phase 2: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}, {'id': 'OG005', 'title': 'Phase 2: Placebo High', 'description': 'Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 4 to Week 8', 'description': 'AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the SAF which included all participants who received at least one dose of study treatment during phase 2 (week 4 to week 8).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.71', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-4.05', 'spread': '1.116', 'groupId': 'OG001'}, {'value': '-6.33', 'spread': '0.793', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': '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 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the FAS population. Here, "Number of participants analyzed" signifies participants evaluable for msDBP at Week 4 or LOCF for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo Low', 'description': 'Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.'}, {'id': 'OG002', 'title': 'Phase 2: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG003', 'title': 'Phase 2: Placebo Mid', 'description': 'Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.'}, {'id': 'OG004', 'title': 'Phase 2: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}, {'id': 'OG005', 'title': 'Phase 2: Placebo High', 'description': 'Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '1.025', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '1.012', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '1.502', 'groupId': 'OG002'}, {'value': '1.52', 'spread': '1.248', 'groupId': 'OG003'}, {'value': '0.37', 'spread': '1.052', 'groupId': 'OG004'}, {'value': '1.51', 'spread': '1.009', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 to endpoint (Week 8 or LOCF)', 'description': '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 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the FAS population. Here, "Number of participants analyzed" signifies participants evaluable for msDBP at Week 8 or LOCF for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.65', 'spread': '0.613', 'groupId': 'OG000'}, {'value': '-4.51', 'spread': '1.064', 'groupId': 'OG001'}, {'value': '-7.23', 'spread': '0.711', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': '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).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the FAS population. Here, "Number of participants analyzed" signifies participants evaluable for MAP at Week 4 (or LOCF) for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo Low', 'description': 'Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.'}, {'id': 'OG002', 'title': 'Phase 2: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG003', 'title': 'Phase 2: Placebo Mid', 'description': 'Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.'}, {'id': 'OG004', 'title': 'Phase 2: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}, {'id': 'OG005', 'title': 'Phase 2: Placebo High', 'description': 'Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '0.864', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.964', 'groupId': 'OG001'}, {'value': '-0.27', 'spread': '1.239', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '1.14', 'groupId': 'OG003'}, {'value': '-0.41', 'spread': '0.885', 'groupId': 'OG004'}, {'value': '1.37', 'spread': '0.918', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 to endpoint (Week 8 or LOCF)', 'description': 'MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of DBP and one third of difference between SBP and DBP i.e. MAP = DBP+1/3\\*(SBP-DBP).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '58.5', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': 'Treatment responders were defined as participants with msSBP less than 95th percentile (for age, gender and height) or a 7 mmHg decrease in msSBP from the baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the FAS population. Here, "Number of participants analyzed" signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'title': 'MASBP (n=58, 29, 65)', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '6.48', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '7.15', 'groupId': 'OG002'}]}]}, {'title': 'MADBP (n=58, 29, 65)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '5.33', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '4.41', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '6.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': 'Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. The participants who were selected for this evaluation wore the ABPM device for 24 hours, returned to the clinic upon completion of the 24-hour monitoring period for removal of device and BP assessments. The ABPM device was pre-set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 - 24 hours.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here 'Number of participants analyzed' signifies those participants evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'title': 'Day time (n= 58, 29, 65)', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '1.031', 'groupId': 'OG000'}, {'value': '-6.76', 'spread': '1.381', 'groupId': 'OG001'}, {'value': '-6.56', 'spread': '0.95', 'groupId': 'OG002'}]}]}, {'title': 'Night time (n= 57, 29, 65)', 'categories': [{'measurements': [{'value': '-2.55', 'spread': '1.035', 'groupId': 'OG000'}, {'value': '-4.67', 'spread': '1.381', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '0.95', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Day time was defined as the average of the hourly means between 6 am and 10 pm while the night time mean was the average of the hourly means between 10 pm and 6 am.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'title': 'MASBP', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '5.47', 'groupId': 'OG001'}, {'value': '-6', 'spread': '6.19', 'groupId': 'OG002'}]}]}, {'title': 'MADBP', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '4.19', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '5.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': 'ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Dippers were defined as those participants in whom there was a decrease in mean night time (6pm - 6am) ABPM more than or equal to (≥ ) 10% as compared to average daytime (6am -6pm) ABPM.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, "Number of participants analyzed" signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.'}, {'id': 'OG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'OG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}], 'classes': [{'title': 'MASBP', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '7.21', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '5.54', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '9.39', 'groupId': 'OG002'}]}]}, {'title': 'MADBP', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '4.45', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '7.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': 'ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non-dippers were defined as those participants in whom there was a decrease in mean night time ABPM less than 10% as compared to average daytime ABPM.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, "Number of participants analyzed" signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren Low (6.25/12.5/25 mg)', 'description': 'During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.\n\nDuring Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment.'}, {'id': 'FG001', 'title': 'Aliskiren Mid (37.5/75/150 mg)', 'description': 'During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.\n\nDuring Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment.'}, {'id': 'FG002', 'title': 'Aliskiren High (150/300/600 mg)', 'description': 'During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.\n\nDuring Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment.'}], 'periods': [{'title': 'Dose Response Phase (Phase 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Placebo-controlled Withdrawal (Phase 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '102'}]}, {'type': 'Started Aliskiren Treament', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'Completed Aliskiren Treament', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'Started Placebo Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'Completed Placebo Treament', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 51 centers in 8 countries.', 'preAssignmentDetails': 'A total of 334 participants were screened and placed in screening phase of single blind placebo washout period for up to a maximum of three weeks. Out of 334, 268 participants were randomized in Phase 1 including 1 mis-randomized participants who did not receive any medication. Therefore total of 267 was enrolled in this study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '267', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: Aliskiren Low (6.25/12.5/25 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight greater than or equal to (≥) 20 kilogram (kg) to less than (\\< ) 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and less than or equal to (≤)150 kg received 25 mg of aliskiren.'}, {'id': 'BG001', 'title': 'Phase 1: Aliskiren Mid (37.5/75/150 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.'}, {'id': 'BG002', 'title': 'Phase 1: Aliskiren High (150/300/600 mg)', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'spread': '3.27', 'groupId': 'BG000'}, {'value': '11.6', 'spread': '3.29', 'groupId': 'BG001'}, {'value': '11.8', 'spread': '3.5', 'groupId': 'BG002'}, {'value': '11.8', 'spread': '3.36', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Children 6 - 11 years', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}]}, {'title': 'Adolescents 12 - 17 years', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis was performed in the full analysis set population consisted of all participants who were randomized into the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-15', 'studyFirstSubmitDate': '2010-06-23', 'resultsFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2010-06-23', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-15', 'studyFirstPostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)', 'timeFrame': 'Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))', 'description': '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 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.'}, {'measure': 'Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)', 'timeFrame': 'Week 4 to endpoint (Week 8 or LOCF)', 'description': '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 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)', 'timeFrame': 'Baseline up to Week 4', 'description': 'Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.'}, {'measure': 'Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)', 'timeFrame': 'From Week 4 to Week 8', 'description': 'AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.'}, {'measure': 'Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': '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 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.'}, {'measure': 'Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)', 'timeFrame': 'Week 4 to endpoint (Week 8 or LOCF)', 'description': '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 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.'}, {'measure': 'Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': '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).'}, {'measure': 'Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)', 'timeFrame': 'Week 4 to endpoint (Week 8 or LOCF)', 'description': 'MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of DBP and one third of difference between SBP and DBP i.e. MAP = DBP+1/3\\*(SBP-DBP).'}, {'measure': 'Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': 'Treatment responders were defined as participants with msSBP less than 95th percentile (for age, gender and height) or a 7 mmHg decrease in msSBP from the baseline.'}, {'measure': 'Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': 'Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. The participants who were selected for this evaluation wore the ABPM device for 24 hours, returned to the clinic upon completion of the 24-hour monitoring period for removal of device and BP assessments. The ABPM device was pre-set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 - 24 hours.'}, {'measure': 'Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)', 'timeFrame': 'Baseline to Week 4', 'description': 'ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Day time was defined as the average of the hourly means between 6 am and 10 pm while the night time mean was the average of the hourly means between 10 pm and 6 am.'}, {'measure': 'Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': 'ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Dippers were defined as those participants in whom there was a decrease in mean night time (6pm - 6am) ABPM more than or equal to (≥ ) 10% as compared to average daytime (6am -6pm) ABPM.'}, {'measure': 'Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1)', 'timeFrame': 'Baseline to endpoint (Week 4 or LOCF)', 'description': 'ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non-dippers were defined as those participants in whom there was a decrease in mean night time ABPM less than 10% as compared to average daytime ABPM.'}]}, 'conditionsModule': {'keywords': ['Pediatric hypertension', 'primary hypertension', 'secondary hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004\n* msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004\n\nExclusion Criteria:\n\n* Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition\n* Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease\n* msSBP ≥ 25% above the 95th percentile\n* Second or third degree heart block without a pacemaker\n* AST/SGOT or ALT/SGPT \\>3 times the upper limit of the reference range\n* Total bilirubin \\> 2 times the upper limit of the reference range\n* Creatinine clearance \\< 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate \\[GFR\\]), based on the serum creatinine concentration obtained at the screening visit)\n* WBC count \\< 3000/mm³\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01150357', 'briefTitle': 'Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age', 'orgStudyIdInfo': {'id': 'CSPP100A2365'}, 'secondaryIdInfos': [{'id': '2009-017028-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose Aliskiren', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \\< 50 kg received 6.25 mg; ≥50 kg and \\< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.', 'interventionNames': ['Drug: Aliskiren (6.25/12.5/25 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Mid dose', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 37.5 mg; ≥50 kg and \\< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.', 'interventionNames': ['Drug: Aliskiren (37.5/75/150 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'High dose', 'description': 'Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \\< 50 kg received 150 mg; ≥50 kg and \\< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.', 'interventionNames': ['Drug: Aliskiren (150/300/600 mg)']}], 'interventions': [{'name': 'Aliskiren (6.25/12.5/25 mg)', 'type': 'DRUG', 'description': 'Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.', 'armGroupLabels': ['Low Dose Aliskiren']}, {'name': 'Aliskiren (37.5/75/150 mg)', 'type': 'DRUG', 'description': 'Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.', 'armGroupLabels': ['Mid dose']}, {'name': 'Aliskiren (150/300/600 mg)', 'type': 'DRUG', 'description': 'Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.', 'armGroupLabels': ['High dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0006', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30721', 'city': 'Dalton', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.7698, 'lon': -84.97022}}, {'zip': '83501', 'city': 'Lewiston', 'state': 'Idaho', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.41655, 'lon': -117.01766}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novartis 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