Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-03 @ 8:58 PM
Study NCT ID:
NCT00328393
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2006-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pioglitazone on Ambulatory Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2006-05-17', 'studyFirstSubmitQcDate': '2006-05-17', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median of systolic 24-hour ambulatory blood pressure', 'timeFrame': '8 weeks', 'description': 'Change of 24-hour blood pressure after 8 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Median of 24-hour diastolic ambulatory blood pressure', 'timeFrame': '8 weeks', 'description': 'Change of 24-hour diastolic blood pressure after 8 weeks of treatment'}]}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['Hypertension', 'Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45-75 years\n* Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)\n* Casual blood pressure \\> = 130/80 mmHg, \\< 160/100 mmHg\n\nExclusion Criteria:\n\n* Therapy with insulin\n* Combination therapy of sulfonyl-urea und metformin\n* Therapy with nateglinid, repaglinid or an other substance of this drug family\n* Allergy against pioglitazone or other composites of the tablet\n* History of heart failure (NYHA I bis IV)\n* Hepatic insufficiency\n* Transaminases \\> 2.5-fold of the upper normal limit\n* End-stage renal failure\n* Syndrome of polycystic ovaries\n* Absence of effective contraception in women of childbearing potential\n* Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00328393', 'briefTitle': 'Effect of Pioglitazone on Ambulatory Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Effect of Pioglitazone on Ambulatory Blood Pressure', 'orgStudyIdInfo': {'id': '2005-000570-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'description': 'Pioglitazone 45 mg, 8 weeks', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'description': '45 mg 8 weeks', 'armGroupLabels': ['Pioglitazone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'CRC Medical Department IV', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Roland E Schmieder, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erlangen-Nürnberg, Medical Department 4'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}