Viewing Study NCT02885558


Ignite Creation Date: 2025-12-25 @ 12:19 AM
Ignite Modification Date: 2026-01-06 @ 10:16 AM
Study NCT ID: NCT02885558
Status: COMPLETED
Last Update Posted: 2021-06-01
First Post: 2016-08-26
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Role of Calcium Channels in Vascular Function
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C066425', 'term': 'efonidipine'}, {'id': 'D009543', 'term': 'Nifedipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular function', 'timeFrame': '8 weeks', 'description': 'Hemodynamic response to femoral arterially infused vasoactive substances'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Receptors, Calcium Channel Blocker'], 'conditions': ['Endothelium, Vascular']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20 - 30 and 60-70\n* BMI \\< 30\n\nExclusion Criteria:\n\n* Hypertension (\\>150/90 mmHg)\n* Smoking\n* Physical activity \\>2 hours/week\n* Known chronic diseases\n* Pregnancy or birth within 3 month\n* Alcohol misuse'}, 'identificationModule': {'nctId': 'NCT02885558', 'briefTitle': 'Role of Calcium Channels in Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Role of T-type Calcium Channels in Vascular Function', 'orgStudyIdInfo': {'id': '47880'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L + T-type', 'description': '8 weeks treatment with efonidipine (1 week 1x20mg, 7 weeks 2x20mg)', 'interventionNames': ['Drug: Efonidipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-Type', 'description': '8 weeks treatment with nifedipine (1 week 1x20mg, 7 weeks 2x20mg)', 'interventionNames': ['Drug: Nifedipine']}], 'interventions': [{'name': 'Efonidipine', 'type': 'DRUG', 'otherNames': ['Landel (efonidipine)'], 'description': '8 weeks treatment with either efonidipine', 'armGroupLabels': ['L + T-type']}, {'name': 'Nifedipine', 'type': 'DRUG', 'otherNames': ['Adalat (nifedipine)'], 'description': '8 weeks treatment with either nifedipine', 'armGroupLabels': ['L-Type']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Centre for Phsical Activity Research', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Cardiovascular and Renal Research', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stefan Mortensen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}