Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT05144360
Status:
WITHDRAWN
Last Update Posted:
2023-09-08
First Post:
2021-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Strategy review', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated hemoglobin', 'timeFrame': '120 days', 'description': 'Changes from baseline in glycated hemoglobin'}, {'measure': 'Systolic blood pressure (SBP)', 'timeFrame': '120 days', 'description': 'Changes from baseline in SBP in ambulatory blood pressure monitoring'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '150 days', 'description': 'Incidence and severity of adverse events recorded during the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Type II Diabetes Mellitus'], 'conditions': ['Hypertension Associated', 'Type II Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Atenas association in the treatment of type 2 diabetes mellitus and hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;\n* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;\n* Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* History of alcohol abuse or illicit drug use;\n* Participation in a clinical trial in the year prior to this study;\n* Pregnancy or risk of pregnancy and lactating patients;\n* Known hypersensitivity to any of the formula compounds;\n* Type 1 diabetes mellitus;\n* Known or suspected secondary hypertension.'}, 'identificationModule': {'nctId': 'NCT05144360', 'acronym': 'ATENAS', 'briefTitle': 'Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension', 'orgStudyIdInfo': {'id': 'EMS0220-ATENAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atenas association', 'description': 'The study is triple-dummy. The patient must take 3 tablets once a day, as follows:\n\n1 tablet Atenas, oral;\n\n1 tablet empagliflozin placebo, oral;\n\n1 tablet telmisartan + amlodipine placebo, oral.', 'interventionNames': ['Drug: Atenas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Empagliflozin + telmisartan + amlodipine', 'description': 'The patient must take 3 tablets once a day, as follows:\n\n1 tablet Atenas placebo, oral;\n\n1 tablet empagliflozin, oral;\n\n1 tablet telmisartan + amlodipine, oral.', 'interventionNames': ['Drug: Atenas placebo']}], 'interventions': [{'name': 'Atenas', 'type': 'DRUG', 'description': 'ATENAS 1 coated tablet, once a day EMPAGLIFLOZIN PLACEBO Empagliflozin placebo 1 coated tablet, once a day TELMISARTAN + AMLODIPINE PLACEBO Telmisartan + amlodipine 1 coated tablet, once a day', 'armGroupLabels': ['Atenas association']}, {'name': 'Atenas placebo', 'type': 'DRUG', 'description': 'Drug: EMPAGLIFLOZIN Empagliflozin 25 mg 1 coated tablet, once a day. Drug: TELMISARTAN Telmisartan + Amlodipine 40 + 5/80 +5 mg 1 coated tablet, once a day ATENAS PLACEBO Atenas placebo 1 coated tablet, once a day', 'armGroupLabels': ['Empagliflozin + telmisartan + amlodipine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}