Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Tarka Therapy', 'description': 'Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.', 'otherNumAtRisk': 15873, 'otherNumAffected': 0, 'seriousNumAtRisk': 14693, 'seriousNumAffected': 16}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14693, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12571', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarka Therapy', 'description': 'Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.'}], 'classes': [{'title': 'Systolic blood pressure change from baseline', 'categories': [{'measurements': [{'value': '-28.5', 'spread': '14.8', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure change from baseline', 'categories': [{'measurements': [{'value': '-16.1', 'spread': '9.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months/study end', 'description': 'Participants were to be followed for 6 months. Changes in systolic and diastolic blood pressure were assessed by comparing the blood pressure measurements obtained at the end of Tarka treatment (approximately 6 months) to baseline values. For this analysis of effectiveness the last available value was considered the analysis time point "end of study".', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2122 participants were excluded from this analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Target Blood Pressure (Less Than 140/90) at Study End and the Need for Other Antihypertensive Drugs, Clustered by Type(s) of Drugs Added to Tarka.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12571', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarka Therapy', 'description': 'Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.'}], 'classes': [{'title': 'Achieved target blood pressure', 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000'}]}]}, {'title': 'Did not achieve target blood pressure', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka only', 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and 1 antihypertensive drug', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and a beta blocking agent', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and an ACE-inhibitor', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and a calcium antagonist', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and a diuretic', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and an AT-II receptor antagonist', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and 1 Other antihypertensive drug', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and an Unknown antihypertensive drug', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Taking Tarka and more than 1 antihypertensive drug', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The percentages of participants achieving and not achieving the target blood pressure of less than 140/90 mmHg at the end of the study are presented. Percentages of participants taking Tarka only or taking Tarka plus another antihypertensive drug are summarized by type of drug: beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, diuretics, and angiotensin II (AT-II) receptor antagonists. Participants taking drugs that did not fit any of the above groups (Other), unknown drugs (Unknown), or more than one additional antihypertensive agent are also summarized.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '2122 participants were excluded from the analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).'}, {'type': 'SECONDARY', 'title': 'Evaluation of Adverse Events (AEs) Leading to Discontinuation of Tarka and a Summary of All AEs Possibly or Probably Related to Tarka by Frequency and Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14693', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarka Therapy', 'description': 'Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.'}], 'classes': [{'title': 'Any AE that led to discontinuation (d/c) of Tarka', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}]}]}, {'title': 'AEs possibly or probably related to Tarka', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}]}]}, {'title': 'a) Severity: Mild', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'b) Severity: Moderate', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'c) Severity: Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'd) Severity: Unknown', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Any AE possibly/probably related that led to d/c', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}]}]}, {'title': 'a) Severity: Mild', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'b) Severity: Moderate', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'c) Severity: Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'd) Severity: Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The number of AEs leading to Tarka discontinuation are summarized. AEs that were considered by the investigator to be possibly or probably related to Tarka are summarized by the severity of the AE (classified as mild, moderate, or severe). AEs considered possibly or probably related to Tarka that led to the discontinuation of Tarka are also presented by severity.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis used the safety analysis population, which included any participant who took at least one dose of Tarka and had at least one follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tarka Therapy', 'description': 'Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15873'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14442'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1431'}]}], 'dropWithdraws': [{'type': 'No Documentation of Tarka Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '739'}]}, {'type': 'No Documentation Available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '437'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '157'}]}, {'type': 'Reason Unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Financial Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Lack of Effectiveness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Improved Status of Participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'No Follow-up Documentation Available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '15,873 participants enrolled in the study. Of these, documentation was available for 15,436 participants. 743 participants were excluded for the following reasons: No Tarka therapy documentation (739) and no follow-up data provided (4), leaving a study population of 14,693. No group assignments were made as the study design was observational.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14693', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tarka Therapy', 'description': 'Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 years of age or younger', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Over 18 and less than 65', 'categories': [{'measurements': [{'value': '10565', 'groupId': 'BG000'}]}]}, {'title': '65 and older', 'categories': [{'measurements': [{'value': '4085', 'groupId': 'BG000'}]}]}, {'title': 'Age not reported', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '7559', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '7034', 'groupId': 'BG000'}]}]}, {'title': 'Gender not reported', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '309', 'groupId': 'BG000'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '5643', 'groupId': 'BG000'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '1251', 'groupId': 'BG000'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '2085', 'groupId': 'BG000'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '3179', 'groupId': 'BG000'}]}]}, {'title': 'Slovenia', 'categories': [{'measurements': [{'value': '1238', 'groupId': 'BG000'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '988', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time Since Diagnosis of Essential Hypertension', 'classes': [{'title': 'At study inclusion', 'categories': [{'measurements': [{'value': '249', 'groupId': 'BG000'}]}]}, {'title': 'Less than 1 year', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}, {'title': 'Between 1 and 2 years', 'categories': [{'measurements': [{'value': '1536', 'groupId': 'BG000'}]}]}, {'title': 'Between 2 and 3 years', 'categories': [{'measurements': [{'value': '1573', 'groupId': 'BG000'}]}]}, {'title': 'Between 3 and 5 years', 'categories': [{'measurements': [{'value': '2482', 'groupId': 'BG000'}]}]}, {'title': 'Between 5 and 10 years', 'categories': [{'measurements': [{'value': '4187', 'groupId': 'BG000'}]}]}, {'title': '10 years or more', 'categories': [{'measurements': [{'value': '4153', 'groupId': 'BG000'}]}]}, {'title': 'Time since diagnosis not reported', 'categories': [{'measurements': [{'value': '405', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Risk Factors for Developing Diabetes', 'classes': [{'title': 'Positive Family History of Diabetes', 'categories': [{'measurements': [{'value': '2891', 'groupId': 'BG000'}]}]}, {'title': 'Obesity', 'categories': [{'measurements': [{'value': '3661', 'groupId': 'BG000'}]}]}, {'title': 'Impaired Fasting Glucose (IFG)', 'categories': [{'measurements': [{'value': '506', 'groupId': 'BG000'}]}]}, {'title': 'Positive Family History and Obesity', 'categories': [{'measurements': [{'value': '2983', 'groupId': 'BG000'}]}]}, {'title': 'Positive Family History and IFG', 'categories': [{'measurements': [{'value': '563', 'groupId': 'BG000'}]}]}, {'title': 'Obesity and IFG', 'categories': [{'measurements': [{'value': '1344', 'groupId': 'BG000'}]}]}, {'title': 'Positive Family History, Obesity, and IFG', 'categories': [{'measurements': [{'value': '1091', 'groupId': 'BG000'}]}]}, {'title': 'Diabetes', 'categories': [{'measurements': [{'value': '288', 'groupId': 'BG000'}]}]}, {'title': 'Risk factors not reported', 'categories': [{'measurements': [{'value': '1366', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'spread': '4.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.1', 'spread': '15.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '97.8', 'spread': '13.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15436}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-15', 'studyFirstSubmitDate': '2010-03-01', 'resultsFirstSubmitDate': '2011-03-04', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-15', 'studyFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End', 'timeFrame': 'Baseline to 6 months/study end', 'description': 'Participants were to be followed for 6 months. Changes in systolic and diastolic blood pressure were assessed by comparing the blood pressure measurements obtained at the end of Tarka treatment (approximately 6 months) to baseline values. For this analysis of effectiveness the last available value was considered the analysis time point "end of study".'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Target Blood Pressure (Less Than 140/90) at Study End and the Need for Other Antihypertensive Drugs, Clustered by Type(s) of Drugs Added to Tarka.', 'timeFrame': '6 months', 'description': 'The percentages of participants achieving and not achieving the target blood pressure of less than 140/90 mmHg at the end of the study are presented. Percentages of participants taking Tarka only or taking Tarka plus another antihypertensive drug are summarized by type of drug: beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, diuretics, and angiotensin II (AT-II) receptor antagonists. Participants taking drugs that did not fit any of the above groups (Other), unknown drugs (Unknown), or more than one additional antihypertensive agent are also summarized.'}, {'measure': 'Evaluation of Adverse Events (AEs) Leading to Discontinuation of Tarka and a Summary of All AEs Possibly or Probably Related to Tarka by Frequency and Severity', 'timeFrame': '6 months', 'description': 'The number of AEs leading to Tarka discontinuation are summarized. AEs that were considered by the investigator to be possibly or probably related to Tarka are summarized by the severity of the AE (classified as mild, moderate, or severe). AEs considered possibly or probably related to Tarka that led to the discontinuation of Tarka are also presented by severity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Effectiveness and tolerability of Tarka', 'Hypertensive patients', 'Diabetes mellitus', 'Observational study'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of this post-marketing observational study (PMOS) is to provide data on the effectiveness and tolerability of Tarka in patients with a high risk of developing diabetes mellitus, as prescribed by the physicians in a community setting and in accordance with the terms of the local marketing authorization. The following specific questions will be addressed:\n\n* Effectiveness of Tarka in lowering the blood pressure in hypertensive patients being at high risk of developing diabetes, not controlled on single-drug therapy.\n* Tolerability of Tarka as assessed by withdrawal rates.', 'detailedDescription': 'This is a non-interventional, observational, open-label, multicountry, multicenter post-marketing study in which Tarka is prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication. Patients with a high risk of developing diabetes mellitus treated by secondary care specialists (such as internal medicine specialists, nephrologists, endocrinologists, etc.), whose hypertension is not controlled on single-drug therapy will be included.\n\nThe assignment of the patient to the treatment with Tarka is not decided in advance by this protocol but falls within current practice. The prescription of Tarka is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients.\n\nEach patient will be treated at the physician\'s discretion. Dosing schedule should be in the accordance with the locally approved Summary of Product Characteristics (SmPC). Physicians will be provided with a study kit that includes a protocol, Tarka\'s locally approved SmPC, and case reports forms for each patient to be enrolled.\n\nThe patient\'s demographic data, height, weight and waist circumference will be reported in the Inclusion visit. The previous antihypertensive therapy should be noted (generic name of the drug and total daily dose). All other drugs the patient currently receives for cardiovascular disease treatment should be recorded as well.\n\nThe patient will then be followed via regular office visits as determined by the physician. As this study is observational in nature, patient follow-up is not interventional and is left to the judgment of each physician within the 6-month period, which defines the survey for each patient. For indicative purposes, follow-up of participant should enable 3 patient visits during this period. For these reasons, the most likely visits are defined as "Inclusion visit" at which treatment with Tarka is to be commenced, and then "Follow-up visit Month 3 " and "Follow-up visit Month 6", although dates will depend only on the decision of the physician. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a high risk of developing diabetes mellitus treated by secondary care specialists (such as internal medicine specialists, nephrologists, endocrinologists, etc.), whose hypertension is not controlled on single-drug therapy will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of either gender (more than 18 years of age), with established diagnosis of essential hypertension (systolic blood pressure/ diastolic blood pressure greater than 140/90 mmHg)\n* Patients not controlled on single-drug therapy and decision was made to introduce Tarka\n* Patients with a high risk of developing diabetes mellitus (defined according British Medical Society guidelines) with at least one of the following symptoms:\n\n * Positive family history of diabetes or\n * Obesity defined by a Body Mass Index (BMI) greater than 30 kg/m\\^2 or a waist circumference greater than 102 cm (males) or greater than 88 cm (females) or\n * Impaired fasting plasma glucose (FPG) levels of 6.1 to 7.0 mmol/l (100-126 mg/dl)\n\nExclusion Criteria:\n\n* Patients with known or established Type 2 diabetes mellitus\n* The use of Tarka is contraindicated in the following patients:\n\n * Hypersensitive to the active substances or to any of the inactive ingredients\n * With cardiogenic shock\n * With second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker\n * With sick sinus syndrome - except in patients with a functioning artificial pacemaker\n * With atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome\n * With existing history of angioedema associated with administration of an angiotensin-converting enzyme (ACE) inhibitor\n * With severe renal or severe liver impairment\n * In pregnant women (women of childbearing potential who are unwilling to use contraception should not be included)\n * Lactating women'}, 'identificationModule': {'nctId': 'NCT01079195', 'acronym': 'TARDIA', 'briefTitle': 'Effectiveness and Tolerability of Tarka® in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Effectiveness and Tolerability of Tarka in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus, Not Controlled on Single-drug Therapy: A Multicountry, Multicenter, Post-marketing Observational Study in the Routine Clinical Use', 'orgStudyIdInfo': {'id': 'P10-299'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Patient group with Hypertension', 'description': 'Single Patient group with Hypertension'}]}, 'contactsLocationsModule': {'locations': [{'zip': 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{'city': 'Brno', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 29044', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '550 01', 'city': 'Broumov', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 29693', 'geoPoint': {'lat': 50.58566, 'lon': 16.33181}}, {'zip': '550 01', 'city': 'Broumov', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 29694', 'geoPoint': {'lat': 50.58566, 'lon': 16.33181}}, {'zip': '69002', 'city': 'Břeclav', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 28646', 'geoPoint': {'lat': 48.75897, 'lon': 16.88203}}, {'zip': '273 43', 'city': 'Buštěhrad', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 28874', 'geoPoint': {'lat': 50.15594, 'lon': 14.18897}}, {'zip': '35002', 'city': 'Cheb', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 28684', 'geoPoint': {'lat': 50.07963, 'lon': 12.37392}}, {'zip': '35002', 'city': 'Cheb', 'country': 'Czechia', 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'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '370 04', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 28651', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '370 06', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 28798', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '371 27', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 28877', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '737 01', 'city': 'Český Těšín', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 29118', 'geoPoint': {'lat': 49.74613, 'lon': 18.62613}}, {'zip': '27034', 'city': 'Čistá', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 28854', 'geoPoint': {'lat': 50.02796, 'lon': 13.57048}}, {'zip': '405 01', 'city': 'Děčín', 'country': 'Czechia', 'facility': 'Site Reference ID/Investigator# 28696', 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