Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01195805
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2010-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D000584', 'term': 'Amiloride'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2010-09-03', 'studyFirstSubmitQcDate': '2010-09-03', 'lastUpdatePostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bloodpressure', 'timeFrame': '24-hours and examination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood pressure, PWV, HRV, PWV, potassium'], 'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.', 'detailedDescription': 'Purpose of the study is to examine the effect of amiloride and spironolactone on\n\n1. Renal function (GFR, u-AQP2, u-ENaCĪ², u-cAMP, u-PGE2, CH20, FENa, FEK),\n2. Pulsewave velocity, augmentation index central bloodpressure,\n3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and\n4. Ambulatory bloodpressure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hypertension,\n* BMI 18,5-30,\n* non-smoker\n\nExclusion Criteria:\n\n* Smoking\n* Not using contraceptives\n* Other illnesses\n* Drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01195805', 'acronym': 'hass', 'briefTitle': 'The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'The Effect of Amiloride and Spironolactone on Renovascular and Cardiovascular Variables in Patients With Essential Hypertension in a Doubleblinded, Randomized, Placebo-controlled, Crossover Study.', 'orgStudyIdInfo': {'id': 'MED.RES.HOS.2010.03.SKM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amiloride', 'interventionNames': ['Drug: Amiloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spironolactone', 'interventionNames': ['Drug: Spironolactone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 tablet twice a day for 28 days', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Spironolactone', 'type': 'DRUG', 'description': '1 tablet twice a day for 28 days', 'armGroupLabels': ['Spironolactone']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '1 tablet twice a day for 28 days', 'armGroupLabels': ['Placebo']}, {'name': 'Amiloride', 'type': 'DRUG', 'description': '1 tablet twice a day for 28 days', 'armGroupLabels': ['Amiloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Departments of medical research and medicine', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Solveig K Matthesen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departments of medical research and medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Erling Bjerregaard Pedersen', 'investigatorAffiliation': 'Regional Hospital Holstebro'}}}}