Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-29 @ 9:49 AM
Study NCT ID:
NCT00865020
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}, {'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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 (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '13 weeks', 'description': 'Safety Set consisting of all participants who received at least one dose of double-blind study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.', 'otherNumAtRisk': 411, 'otherNumAffected': 15, 'seriousNumAtRisk': 411, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.', 'otherNumAtRisk': 403, 'otherNumAffected': 32, 'seriousNumAtRisk': 403, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.'}, {'id': 'OG001', 'title': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '0.466', 'groupId': 'OG000'}, {'value': '6.51', 'spread': '0.461', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks, 13 weeks', 'description': "An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.'}, {'type': 'SECONDARY', 'title': 'Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.'}, {'id': 'OG001', 'title': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.09', 'spread': '0.328', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '0.324', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks, 13 weeks', 'description': "An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.'}, {'type': 'SECONDARY', 'title': 'Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.'}, {'id': 'OG001', 'title': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.'}], 'classes': [{'title': 'MASBP', 'categories': [{'measurements': [{'value': '-8.39', 'spread': '0.542', 'groupId': 'OG000'}, {'value': '-5.59', 'spread': '0.539', 'groupId': 'OG001'}]}]}, {'title': 'MADBP', 'categories': [{'measurements': [{'value': '-5.05', 'spread': '0.379', 'groupId': 'OG000'}, {'value': '-3.44', 'spread': '0.377', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 13 weeks', 'description': "An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set consisting of all participants randomized to treatment with measurements at baseline and day 7 of the withdrawal period.'}, {'type': 'SECONDARY', 'title': 'Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.'}, {'id': 'OG001', 'title': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.'}], 'classes': [{'title': 'Double-Blind Period (n1=374,371)', 'categories': [{'measurements': [{'value': '-15.22', 'spread': '0.744', 'groupId': 'OG000'}, {'value': '-14.64', 'spread': '0.744', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Interruption Period (n2=369,363)', 'categories': [{'measurements': [{'value': '1.26', 'spread': '0.652', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '0.658', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks, 13 weeks', 'description': 'Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis.\n\nThe change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate.\n\nThe change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.'}, {'type': 'SECONDARY', 'title': 'Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.'}, {'id': 'OG001', 'title': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.'}], 'classes': [{'title': 'Double-Blind Period (n1=374,371)', 'categories': [{'measurements': [{'value': '-6.35', 'spread': '0.453', 'groupId': 'OG000'}, {'value': '-6.60', 'spread': '0.453', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Interruption Period (n2=369,363)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.388', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '0.392', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks, 13 weeks', 'description': 'Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis.\n\nThe change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate.\n\nThe change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.'}, {'id': 'FG001', 'title': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '414'}, {'groupId': 'FG001', 'numSubjects': '408'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '357'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomized but discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '1359 participants entered the Placebo Run-In phase which was 1-2 weeks in duration. Those participants completing the Placebo-Run-In Phase were randomized to receive either aliskiren 300 mg or telmisartan 80 mg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'BG000'}, {'value': '408', 'groupId': 'BG001'}, {'value': '822', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.'}, {'id': 'BG001', 'title': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'spread': '11.46', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '11.91', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '11.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '438', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 822}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2009-03-17', 'resultsFirstSubmitDate': '2011-06-22', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-22', 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period', 'timeFrame': '12 weeks, 13 weeks', 'description': "An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors."}], 'secondaryOutcomes': [{'measure': 'Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period', 'timeFrame': '12 weeks, 13 weeks', 'description': "An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors."}, {'measure': 'Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period', 'timeFrame': 'Baseline, 13 weeks', 'description': "An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate."}, {'measure': 'Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period', 'timeFrame': 'Baseline, 12 weeks, 13 weeks', 'description': 'Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis.\n\nThe change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate.\n\nThe change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.'}, {'measure': 'Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period', 'timeFrame': 'Baseline, 12 weeks, 13 weeks', 'description': 'Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis.\n\nThe change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate.\n\nThe change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.'}]}, 'conditionsModule': {'keywords': ['Hypertension', 'ABPM', 'systolic blood pressure', 'diastolic blood pressure', 'cardiovascular disease', 'aliskiren', 'telmisartan'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '40013543', 'type': 'DERIVED', 'citation': 'Wang GM, Li LJ, Fan L, Xu M, Tang WL, Wright JM. Renin inhibitors versus angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD012570. doi: 10.1002/14651858.CD012570.pub2.'}, {'pmid': '23630950', 'type': 'DERIVED', 'citation': 'Williams B, Lacy PS, Baschiera F, Brunel P, Dusing R. Novel description of the 24-hour circadian rhythms of brachial versus central aortic blood pressure and the impact of blood pressure treatment in a randomized controlled clinical trial: The Ambulatory Central Aortic Pressure (AmCAP) Study. Hypertension. 2013 Jun;61(6):1168-76. doi: 10.1161/HYPERTENSIONAHA.111.00763. Epub 2013 Apr 29.'}, {'pmid': '23282123', 'type': 'DERIVED', 'citation': 'Dusing R, Brunel P, Baek I, Baschiera F. Sustained blood pressure-lowering effect of aliskiren compared with telmisartan after a single missed dose. J Clin Hypertens (Greenwich). 2013 Jan;15(1):41-7. doi: 10.1111/jch.12018. Epub 2012 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mean sitting systolic blood pressure ≥ 140 mmHg and \\< 180 mmHg\n* 24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg\n\nExclusion Criteria:\n\n* Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg\n* Patients with Type 1 diabetes mellitus\n* Secondary hypertension of any etiology\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00865020', 'acronym': 'ASSERTIVE', 'briefTitle': 'Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Twelve-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Prolonged Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg in Mild to Moderate Hypertensive Patients With the 24-hour Ambulatory Blood Pressure Measurement After 1 Week of Treatment Withdrawal Study Acronym: ASSERTIVE - AliSkiren Study of Profound antihypERtensive Efficacy in hyperTensIVE Patients', 'orgStudyIdInfo': {'id': 'CSPP100A2408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aliskiren 300 mg', 'description': 'Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.', 'interventionNames': ['Drug: Aliskiren', 'Drug: Placebo to Aliskiren']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan 80 mg', 'description': 'Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.', 'interventionNames': ['Drug: Telmisartan', 'Drug: Placebo to Telmisartan']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'description': 'Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks.', 'armGroupLabels': ['Aliskiren 300 mg']}, {'name': 'Telmisartan', 'type': 'DRUG', 'description': 'Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks.', 'armGroupLabels': ['Telmisartan 80 mg']}, {'name': 'Placebo to Aliskiren', 'type': 'DRUG', 'description': 'Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week.', 'armGroupLabels': ['Aliskiren 300 mg']}, {'name': 'Placebo to Telmisartan', 'type': 'DRUG', 'description': 'Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.', 'armGroupLabels': ['Telmisartan 80 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sorocaba', 'country': 'Brazil', 'facility': 'Investigative Site', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}, {'city': 'Gatineau', 'country': 'Canada', 'facility': 'Investigative Site', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'city': 'Guayaquil', 'country': 'Ecuador', 'facility': 'Investigative Site', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}, {'city': 'Erfurt', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Invesitagtive Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Investigative Site', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Investigative Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Investigative Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Investigative Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Investigative Site', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Investigative Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Westbury', 'country': 'United Kingdom', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.26, 'lon': -2.1875}}, {'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Investigative Site', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}