Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT01822860
Status:
WITHDRAWN
Last Update Posted:
2015-03-25
First Post:
2013-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D002752', 'term': 'Chlorthalidone'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], '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'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D049971', 'term': 'Thiazides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study subjects were not able to be recruited', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2013-04-01', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow mediated vasodilatation', 'timeFrame': '4 weeks', 'description': 'Flow mediated vasodilatation will be measured after one month on each drug and placebo'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypertension', 'Endothelial dysfunction'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation.', 'detailedDescription': 'This is a randomized, double-blind, crossover study to evaluate chlorthalidone and hydrochlorothiazide and their effects on endothelial function in hypertensive patients. Subjects will receive chlorthalidone 12.5 mg, hydrochlorothiazide 25 mg, and placebo each for 4 weeks with a 1 week washout between study periods. Sequence of study drugs will be randomized. Flow mediated vasodilatation will be measured at baseline and after each treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 or older\n* Diagnosis of hypertension\n* Current blood pressure \\> 120/80 mm Hg\n\nExclusion Criteria:\n\n* Use of a thiazide-type diuretic within the last 1 month\n* Known allergy to any study medications\n* History of gout or hyperuricemia\n* SCr \\>/= 1.8 mg/dl or CrCl \\< 25 ml/min\n* Pregnancy or breastfeeding or planning to become pregnant during study period\n* Dementia or cognitive impairment\n* Hypokalemia\n* Acute coronary syndrome or stroke within 6 months\n* Current use of sildenafil, tadalafil, or vardenafil'}, 'identificationModule': {'nctId': 'NCT01822860', 'briefTitle': 'Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'The Effect of Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function in Hypertensive Patients: A Pilot Study', 'orgStudyIdInfo': {'id': '13-16628'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorthalidone 12.5 mg', 'description': 'Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.', 'interventionNames': ['Drug: Chlorthalidone 12.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrochlorothiazide 25 mg', 'description': 'Subjects will receive chlorthalidone, hydrochlorothiazide, and placebo each for 4 weeks in a randomized sequence.', 'interventionNames': ['Drug: Hydrochlorothiazide 25 mg']}], 'interventions': [{'name': 'Chlorthalidone 12.5 mg', 'type': 'DRUG', 'armGroupLabels': ['Chlorthalidone 12.5 mg']}, {'name': 'Hydrochlorothiazide 25 mg', 'type': 'DRUG', 'armGroupLabels': ['Hydrochlorothiazide 25 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Ahmed Aboeata, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}