Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00409903
Status:
COMPLETED
Last Update Posted:
2007-09-14
First Post:
2006-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Eprosartan on Hormones and Kidney Function in Healthy Humans.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C068373', 'term': 'eprosartan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'lastUpdateSubmitDate': '2007-09-13', 'studyFirstSubmitDate': '2006-12-10', 'studyFirstSubmitQcDate': '2006-12-11', 'lastUpdatePostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate'}, {'measure': 'Fractional sodium excretion'}, {'measure': 'Plasma levels of noradrenaline'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in healthy individuals - during baseline conditions and after activation of the sympathetic nervous system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders.\n* Age 18 - 65 years.\n* Body mass index less or equal to 30 kg/m2.\n* Women must use oral hormonal anticonception, use intrauterine anticonceptive device, be sterilized/hysterectomized or be postmenopausal.\n\nExclusion Criteria:\n\n* History or clinical signs of heart, lung, kidney, or endocrine organ disease.\n* Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.\n* Abnormal screening of the urine regarding: albumin and glucose\n* Malignant disease.\n* Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.\n* Alcohol abuse.\n* Smoking.\n* Drug use or abuse.\n* Known intolerance or allergy to eprosartan or sodium nitroprusside.\n* Blood donation within 1 month of the start of the study.'}, 'identificationModule': {'nctId': 'NCT00409903', 'briefTitle': 'The Effect of Eprosartan on Hormones and Kidney Function in Healthy Humans.', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'The Effect of Eprosartan on Vasoactive Hormones and Renal Tubular Function in Healthy Humans.', 'orgStudyIdInfo': {'id': 'MED.RES.HOS.2006.02.HV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Eprosartan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Department of Medical Research, Holstebro Hospital', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Erling B Pedersen, MD, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Medical Research, Holstebro Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}}}}