Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-02-03 @ 12:37 PM
Study NCT ID:
NCT00345202
Status:
COMPLETED
Last Update Posted:
2008-05-15
First Post:
2006-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-14', 'studyFirstSubmitDate': '2006-06-24', 'studyFirstSubmitQcDate': '2006-06-26', 'lastUpdatePostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GFR'}, {'measure': 'RPF'}, {'measure': 'FEna'}, {'measure': 'FELi'}, {'measure': 'CLna'}, {'measure': 'CLli'}]}, 'conditionsModule': {'keywords': ['HMG-COA reductase inhibition', 'GFR', 'RPF', 'FE', 'CL'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'We wanted to test the shortterm effects of HMG-CoA reductase inhibition (atorvastatin) on renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both men and women\n* Age: Between 20-50\n* BMI\\<30\n\nExclusion Criteria:\n\n* Cl. signs or history of disease of heart, lungs, kidneys or endocrine organs.\n* Abnormal lab. tests( haemoglobin, pl. sodium, pl. potassium, pl.creatinine, pl.bilirubin, pl.ALAT, pl. cholesterol, blood glucose)\n* Albuminuria or glucosuria\n* Cancer\n* Art. hypertension\n* Alcohol abuse\n* Med. treatment, except oral contraceptives\n* Pregnancy or breast feeding\n* Blood donation less than 1 month before study'}, 'identificationModule': {'nctId': 'NCT00345202', 'briefTitle': 'Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects.', 'orgStudyIdInfo': {'id': 'MED.RES.HOS.2004.02.LP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HMG-CoA reductase inhibition (atorvastatin)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'state': 'Ringkøbing Countie', 'country': 'Denmark', 'facility': 'Medical research unit, Department of medicin, Holstebro Sygehus', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Erling B. Pedersen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Holstebro Sygehus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}}}}