Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02521233
Status:
WITHDRAWN
Last Update Posted:
2017-01-19
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Candesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}, {'id': 'D002752', 'term': 'Chlorthalidone'}, {'id': 'C505809', 'term': 'hydrochlorothiazide, losartan drug combination'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-08-10', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal', 'timeFrame': '60 days'}], 'secondaryOutcomes': [{'measure': 'Safety will be evaluated by the occurrences of adverse events.', 'timeFrame': '9 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Essential Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Consent of the patient;\n* Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment.\n\nObs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements\n\nExclusion Criteria:\n\n* Patients with any clinically significant disease that in the investigator is opinion can not participate in the study;\n* Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;\n* Morbid obesity or immunocompromised patients;\n* Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;\n* Participants who do not have the two upper limbs;\n* Participants with important electrocardiographic changes;\n* Creatinine clearance - less than 60 mL /min;\n* History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;\n* Microalbuminuria in urine sample greater than 30 mg/g;\n* Patients with history of hypersensitivity to any of the formula compounds;\n* Pregnancy or risk of pregnancy and lactating patients;\n* Participation in clinical trial in the year prior to this study.'}, 'identificationModule': {'nctId': 'NCT02521233', 'briefTitle': 'Efficacy and Safety of Candesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control', 'orgStudyIdInfo': {'id': 'CACEMS0514OR-III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test 1: Candesartan + Chlorthalidone', 'description': 'The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 12,5 mg) a day, in the morning.', 'interventionNames': ['Drug: Candesartan + Chlorthalidone (8mg+12,5mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Test 2: Candesartan + Chlorthalidone', 'description': 'The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 25 mg) a day, in the morning.', 'interventionNames': ['Drug: Candesartan + Chlorthalidone (8 mg + 25 mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator: losartan+hydrochlorothiazide (Hyzaar®)', 'description': 'he patients will take 1 tablet (Losartan 50 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.', 'interventionNames': ['Drug: losartan+hydrochlorothiazide']}], 'interventions': [{'name': 'Candesartan + Chlorthalidone (8mg+12,5mg)', 'type': 'DRUG', 'otherNames': ['Candesartan + Chlorthalidone'], 'armGroupLabels': ['Test 1: Candesartan + Chlorthalidone']}, {'name': 'Candesartan + Chlorthalidone (8 mg + 25 mg)', 'type': 'DRUG', 'otherNames': ['Candesartan + Chlorthalidone'], 'armGroupLabels': ['Test 2: Candesartan + Chlorthalidone']}, {'name': 'losartan+hydrochlorothiazide', 'type': 'DRUG', 'otherNames': ['Hyzaar ®'], 'armGroupLabels': ['Comparator: losartan+hydrochlorothiazide (Hyzaar®)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}