Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-28 @ 2:05 PM
Study NCT ID:
NCT00434967
Status:
COMPLETED
Last Update Posted:
2010-12-16
First Post:
2007-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077793', 'term': 'candesartan cilexetil'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AZTrial_Results_Posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed in order for AstraZeneca to file patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)', 'otherNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Candesartan 32 mg', 'description': 'candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)', 'otherNumAffected': 38, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'HCT 25 mg', 'description': 'HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)', 'otherNumAffected': 22, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Candesartan/HCT 32/25 mg', 'description': 'candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)', 'otherNumAffected': 23, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Electrocardiogram Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 465, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 470, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}, {'value': '464', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)'}, {'id': 'OG001', 'title': 'Candesartan 32 mg', 'description': 'candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}, {'id': 'OG002', 'title': 'HCT 25 mg', 'description': 'HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)'}, {'id': 'OG003', 'title': 'Candesartan/HCT 32/25 mg', 'description': 'candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-7.7', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '-13.9', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}, {'value': '464', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)'}, {'id': 'OG001', 'title': 'Candesartan 32 mg', 'description': 'candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}, {'id': 'OG002', 'title': 'HCT 25 mg', 'description': 'HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)'}, {'id': 'OG003', 'title': 'Candesartan/HCT 32/25 mg', 'description': 'candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-13.1', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-11.6', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '-21.4', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}, {'value': '464', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)'}, {'id': 'OG001', 'title': 'Candesartan 32 mg', 'description': 'candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}, {'id': 'OG002', 'title': 'HCT 25 mg', 'description': 'HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)'}, {'id': 'OG003', 'title': 'Candesartan/HCT 32/25 mg', 'description': 'candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '304', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Controlled sitting SBP and sitting DBP are defined as having sitting SBP \\< 140 mmHg and sitting DBP \\< 90 mmHg at the end of the study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).', 'timeFrame': 'Baseline to 8 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.', 'timeFrame': 'Baseline to 8 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP.', 'timeFrame': 'Baseline to 8 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study).', 'timeFrame': 'Baseline to 8 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study).', 'timeFrame': 'Baseline to 8 weeks', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)'}, {'id': 'FG001', 'title': 'Candesartan 32 mg', 'description': 'candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}, {'id': 'FG002', 'title': 'HCT 25 mg', 'description': 'HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)'}, {'id': 'FG003', 'title': 'Candesartan/HCT 32/25 mg', 'description': 'candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '465'}, {'groupId': 'FG002', 'numSubjects': '470'}, {'groupId': 'FG003', 'numSubjects': '492'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '457'}, {'groupId': 'FG002', 'numSubjects': '461'}, {'groupId': 'FG003', 'numSubjects': '478'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Randomized in error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Patient Disposition Challenges', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Following a screening evaluation, patients underwent a 4-week, single-blind treatment with placebo, after which eligible patients were randomly allocated in a 5:5:5:1 ratio to receive 8 weeks of double-blind treatment either with candesartan/Hydrochlorothiazide (HCT) 32/25 mg or candesartan 32 mg or HCT 25 mg or placebo, respectively.', 'preAssignmentDetails': 'In total, 2207 patients were enrolled in the study at 128 centres in 10 countries, 1772 patients received run in medication and 1524 patients were subsequently randomised to double-blind treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '457', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}, {'value': '486', 'groupId': 'BG003'}, {'value': '1499', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)'}, {'id': 'BG001', 'title': 'Candesartan 32 mg', 'description': 'candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}, {'id': 'BG002', 'title': 'HCT 25 mg', 'description': 'HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)'}, {'id': 'BG003', 'title': 'Candesartan/HCT 32/25 mg', 'description': 'candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '76'}, {'value': '51.7', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '79'}, {'value': '50.9', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '78'}, {'value': '52.7', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '77'}, {'value': '52', 'groupId': 'BG004', 'lowerLimit': '21', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '285', 'groupId': 'BG003'}, {'value': '864', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}, {'value': '635', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2007-02-13', 'resultsFirstSubmitDate': '2009-01-09', 'studyFirstSubmitQcDate': '2007-02-13', 'lastUpdatePostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-29', 'studyFirstPostDateStruct': {'date': '2007-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).', 'timeFrame': '8 weeks', 'description': 'Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.'}, {'measure': 'Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)', 'timeFrame': '8 weeks', 'description': 'Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.'}], 'secondaryOutcomes': [{'measure': 'The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study', 'timeFrame': '8 weeks', 'description': 'Controlled sitting SBP and sitting DBP are defined as having sitting SBP \\< 140 mmHg and sitting DBP \\< 90 mmHg at the end of the study'}, {'measure': 'Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP.', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study).', 'timeFrame': 'Baseline to 8 weeks'}, {'measure': 'To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study).', 'timeFrame': 'Baseline to 8 weeks'}]}, 'conditionsModule': {'keywords': ['Blood pressure reduction', 'combination therapy', 'candesartan cilexetil', 'hydrochlorothiazide'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim is to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32 mg alone, HCT 25 mg alone and placebo in hypertensive adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:\n* Provision of signed Informed Consent\n* Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs (substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo.\n* Mean sitting DBP 90-114 mmHg (value calculated in the eCRF) at Visits 1 and 2\n* Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:\n* Mean sitting DBP of 90-114 mmHg (value calculated in the eCRF) at the end of the 4-week single-blind placebo run-in period. The run-in period should not be shorter than 4 weeks.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant. Pregnancy must be excluded by a negative pregnancy test at Visit 1.\n* Secondary or malignant hypertension\n* Sitting SBP of 180 mmHg or more\n* Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment\n* Angina pectoris requiring more treatment than short-acting nitrates\n* Chronic use of NSAIDs\n* Aortic or mitral valve stenosis\n* Cardiac failure requiring treatment\n* Cardiac arrhythmia requiring treatment\n* Gout\n* Renal artery stenosis or kidney transplantation\n* Intravascular volume depletion\n* Hypersensitivity to any component of the investigational products or to any sulphonamide derived drugs\n* Concomitant disease which may interfere with the assessment of the patient\n* Past or present alcohol or drug abuse, or any condition associated with poor compliance that in the opinion of the investigator might affect the patient's participation in the study\n* Chronic liver disease\n* Concomitant or previous treatment with any other investigational drug within 20 days of enrolment\n* Previous enrolment in the present study"}, 'identificationModule': {'nctId': 'NCT00434967', 'briefTitle': 'Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Randomised, 4-arm Parallel Group, Multicentre, 8-week, Phase III Study to Assess the Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) 32 mg and Hydrochlorothiazide (HCT) 25 mg Compared With CC 32 mg, HCT 25 mg and Placebo in Hypertensive Adults', 'orgStudyIdInfo': {'id': 'D2456C00002'}, 'secondaryIdInfos': [{'id': 'EudraCT No. 2006-003963-30'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '4', 'description': 'Placebo'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Candesartan cilexetil', 'interventionNames': ['Drug: Candesartan cilexetil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Hydrochlorothiazide (HCT)', 'interventionNames': ['Drug: Hydrochlorothiazide']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Candesartan cilexetil + Hydrochlorothiazide Combination', 'interventionNames': ['Drug: Candesartan cilexetil', 'Drug: Hydrochlorothiazide', 'Drug: Candesartan/HCT 32/25 mg']}], 'interventions': [{'name': 'Candesartan cilexetil', 'type': 'DRUG', 'otherNames': ['ATACAND'], 'description': '32 mg oral tablet', 'armGroupLabels': ['1', '2']}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'otherNames': ['HCTZ'], 'description': '25 mg oral tablet', 'armGroupLabels': ['1', '3']}, {'name': 'Candesartan/HCT 32/25 mg', 'type': 'DRUG', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dour', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.39583, 'lon': 3.77792}}, {'city': 'Gozée', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.33461, 'lon': 4.35273}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Linkebeek', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.76781, 'lon': 4.33688}}, {'city': 'Marchovelette', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.52303, 'lon': 4.94059}}, {'city': 'Ronquières', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.60853, 'lon': 4.22081}}, {'city': 'Saint-Médard', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 49.81538, 'lon': 5.32795}}, {'city': 'Steenokkerzel', 'country': 'Belgium', 'facility': 'Research Site'}, {'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'city': 'Ogre', 'country': 'Latvia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.8162, 'lon': 24.61401}}, {'city': 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'facility': 'Research Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Levice', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.21563, 'lon': 18.60705}}, {'city': 'Lučenec', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.33249, 'lon': 19.66708}}, {'city': 'Prešov', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'city': 'Šahy', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.07408, 'lon': 18.94946}}], 'overallOfficials': [{'name': 'Michael Klibaner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Istvan Edes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DEOEC Institute of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}