Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT00443456
Status:
COMPLETED
Last Update Posted:
2009-10-28
First Post:
2007-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Sponsor:
Organization:
Raw JSON
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Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study', 'otherNumAtRisk': 134, 'otherNumAffected': 50, 'seriousNumAtRisk': 134, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gum neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Malignant ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure From Baseline of the Preceding Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).'}, {'id': 'OG001', 'title': 'The Preceding Study 5 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).'}, {'id': 'OG002', 'title': 'The Preceding Study 10 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 0: Baseline (Actual Value)', 'categories': [{'measurements': [{'value': '148.8', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '148.8', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '148.8', 'spread': '8.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-8.7', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '-12.0', 'spread': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-14.8', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '-14.5', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '-15.0', 'spread': '11.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-15.6', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '-15.6', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '-15.7', 'spread': '10.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-16.7', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '-16.9', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '-16.4', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-15.8', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '-17.4', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '-14.1', 'spread': '9.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-15.4', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '-14.6', 'spread': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '-14.7', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '-15.7', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '-13.6', 'spread': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '-13.8', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-14.4', 'spread': '12.4', 'groupId': 'OG001'}, {'value': '-13.2', 'spread': '13.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-13.4', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '-12.2', 'spread': '12.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '-13.9', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '-14.7', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '-13.0', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '-15.7', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '-15.6', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '-15.8', 'spread': '11.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-15.3', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '-16.0', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '-14.5', 'spread': '11.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-15.6', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '-15.0', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '-16.3', 'spread': '11.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure From Baseline of This Long-term Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).'}, {'id': 'OG001', 'title': 'The Preceding Study 5 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).'}, {'id': 'OG002', 'title': 'The Preceding Study 10 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 8: Baseline (Actual Value)', 'categories': [{'measurements': [{'value': '140.1', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '143.2', 'spread': '15.7', 'groupId': 'OG001'}, {'value': '136.8', 'spread': '11.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '-8.9', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '8.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '-11.3', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '9.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-7.1', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '-11.8', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-6.7', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '10.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '-10.1', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '-5.1', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '10.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '-7.0', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '10.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-6.6', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '11.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'PRIMARY', 'title': 'Change in Diastolic Blood Pressure From Baseline of the Preceding Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).'}, {'id': 'OG001', 'title': 'The Preceding Study 5 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).'}, {'id': 'OG002', 'title': 'The Preceding Study 10 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 0: Baseline (Actual Value)', 'categories': [{'measurements': [{'value': '86.3', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '87.6', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '84.8', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-6.4', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '8.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '7.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-7.2', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '7.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '8.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '7.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '-6.9', 'spread': '7.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-7.2', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '-7.0', 'spread': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-8.2', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-7.7', 'spread': '9.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'PRIMARY', 'title': 'Change in Diastolic Blood Pressure From Baseline of This Long-term Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).'}, {'id': 'OG001', 'title': 'The Preceding Study 5 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).'}, {'id': 'OG002', 'title': 'The Preceding Study 10 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 8: Baseline (Actual Value)', 'categories': [{'measurements': [{'value': '83.1', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '85.8', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '80.3', 'spread': '10.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '6.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '6.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '8.8', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '6.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '8.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '8.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '8.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '7.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '7.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '9.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.'}, {'id': 'OG001', 'title': 'Subjects Without Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 0: Baseline (Actual Value)', 'categories': [{'measurements': [{'value': '153.9', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '148.3', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=13, 121)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (n=13, 118)', 'categories': [{'measurements': [{'value': '-13.8', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=12, 119)', 'categories': [{'measurements': [{'value': '-13.5', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-15.8', 'spread': '9.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=12, 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'13.2', 'groupId': 'OG000'}, {'value': '-13.1', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 (n=12, 108)', 'categories': [{'measurements': [{'value': '-9.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-13.6', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 44 (n=11, 108)', 'categories': [{'measurements': [{'value': '-13.7', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-15.4', 'spread': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=9, 107)', 'categories': [{'measurements': [{'value': '-11.1', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '-15.3', 'spread': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=9, 106)', 'categories': [{'measurements': [{'value': '-10.8', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-15.9', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 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'title': 'Subjects Without Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 8: Baseline (Actual Value)', 'categories': [{'measurements': [{'value': '149.1', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '139.2', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (n=13, 118)', 'categories': [{'measurements': [{'value': '-9.0', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=12, 119)', 'categories': [{'measurements': [{'value': '-8.4', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=12, 117)', 'categories': [{'measurements': [{'value': '-12.0', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 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'11.2', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 44 (n=11, 108)', 'categories': [{'measurements': [{'value': '-9.1', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '12.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=9, 107)', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=9, 106)', 'categories': [{'measurements': [{'value': '-7.1', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.'}, {'id': 'OG001', 'title': 'Subjects Without Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 0: Baseline (Actual Value)', 'categories': [{'measurements': [{'value': '85.9', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '86.3', 'spread': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=13, 121)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (n=13, 118)', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=12, 119)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=12, 117)', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=12, 116)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=11, 113)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (n=12, 111)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 (n=12, 111)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n=11, 108)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 (n=12, 108)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '6.8', 'groupId': 'OG000'}, 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Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.'}, {'id': 'OG001', 'title': 'Subjects Without Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 8: Baseline (Actual Value)', 'categories': [{'measurements': [{'value': '86.2', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '82.8', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (n=13, 118)', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=12, 119)', 'categories': [{'measurements': [{'value': '-5.0', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=12, 117)', 'categories': [{'measurements': [{'value': '-5.1', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=12, 116)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=11, 113)', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (n=12, 111)', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 (n=12, 111)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n=11, 108)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 (n=12, 108)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 44 (n=11, 108)', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=9, 107)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=9, 106)', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).'}, {'id': 'OG001', 'title': 'The Preceding Study 5 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).'}, {'id': 'OG002', 'title': 'The Preceding Study 10 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, 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'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \\<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \\>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).'}, {'id': 'OG001', 'title': 'The Preceding Study 5 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).'}, {'id': 'OG002', 'title': 'The Preceding Study 10 mg Sub-set of This Long-term Study', 'description': 'Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then 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[{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \\<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \\>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Last Observation Carried Forward'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.'}, {'id': 'OG001', 'title': 'Subjects Without Concomitant Antihypertensive Agent', 'description': 'Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).'}], 'classes': [{'title': 'Week 8 (n=13, 121)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Week 10 (n=13, 118)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=12, 119)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=12, 117)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=12, 116)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=11, 113)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (n=12, 111)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 (n=12, 111)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n=11, 108)', 'categories': [{'measurements': 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'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=9, 106)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \\<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \\>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Move', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Among subjects who had completed the preceding study (A0531085, NCT00415623), where either Amlodipine 5 mg or 10 mg was administered for 8 weeks, those who were considered to be eligible for enrollment in this long-term study, based on safety and efficacy of the preceding study and who had a treatment compliance rate of at least 80% were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Amlodipine', 'description': 'All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20 to 44 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': '45 to 64 years', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-19', 'studyFirstSubmitDate': '2007-03-02', 'resultsFirstSubmitDate': '2009-06-10', 'studyFirstSubmitQcDate': '2007-03-02', 'lastUpdatePostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-09-08', 'studyFirstPostDateStruct': {'date': '2007-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'timeFrame': 'Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)'}, {'measure': 'Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'timeFrame': 'Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)'}, {'measure': 'Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'timeFrame': 'Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)'}, {'measure': 'Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'timeFrame': 'Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)'}, {'measure': 'Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'timeFrame': '8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \\<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \\>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg'}, {'measure': 'Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent', 'timeFrame': '8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \\<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \\>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg'}], 'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure From Baseline of the Preceding Study', 'timeFrame': 'Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)'}, {'measure': 'Change in Systolic Blood Pressure From Baseline of This Long-term Study', 'timeFrame': 'Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)'}, {'measure': 'Change in Diastolic Blood Pressure From Baseline of the Preceding Study', 'timeFrame': 'Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)'}, {'measure': 'Change in Diastolic Blood Pressure From Baseline of This Long-term Study', 'timeFrame': 'Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)'}, {'measure': 'Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value', 'timeFrame': '8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \\<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \\>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg'}, {'measure': 'Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study', 'timeFrame': '8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks', 'description': 'Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \\<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \\>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0531086&StudyName=Long%20Term%20Study%20For%20Amlodipine%2010mg%20With%20Hypertension%20For%20Whom%20Amlodipine%205mg%20Is%20Insufficient', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).', 'detailedDescription': 'NCT00415623 (protocol A0531085)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety\n* Patients who had a treatment compliance rate of at least 80%\n\nExclusion Criteria:\n\n* The patient who met the discontinuation criteria in the preceding study A0531085'}, 'identificationModule': {'nctId': 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'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Iruma', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.818, 'lon': 139.368}}, {'city': 'Koshigaya', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'city': 'Edogawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Sumida-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}], 'overallOfficials': 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