Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT00345150
Status:
COMPLETED
Last Update Posted:
2006-06-27
First Post:
2006-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019323', 'term': 'omega-N-Methylarginine'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D001120', 'term': 'Arginine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'lastUpdateSubmitDate': '2006-06-24', 'studyFirstSubmitDate': '2006-06-24', 'studyFirstSubmitQcDate': '2006-06-24', 'lastUpdatePostDateStruct': {'date': '2006-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['hypertension', 'nitric oxide', 'renal hemodynamics'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. The results are compared with a group of healthy subjects.', 'detailedDescription': 'The study investigates the effects of Ng-monomethyl-L-arginine (L-NMMA) on:\n\n1. renal hemodynamics (renal plasma flow and glomerular filtration rate)\n2. renal sodium excretion\n3. lithium clearance and fractional lithium excretion\n4. plasma levels of vasoactive hormones\n5. blood pressure and heart rate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Essential hypertension (blood pressure \\> 140/90) with no signs of secondary hypertension\n* P-creatinine \\< 200 µmol/L\n\nExclusion Criteria:\n\n* Anamnestic or clinical signs of heart disease, renal disease, liver disease, neoplastic disease, anemia or cerebro-vascular insult\n* Medication except antihypertensives\n* Drug or alcohol abuse\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00345150', 'briefTitle': 'Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'Phase 1 Study of the Effects of Systemic Nitric Oxide Inhibition With Ng-Monomethyl-L-Arginine on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls', 'orgStudyIdInfo': {'id': 'MED.RES.HOS.1995.01.JNB'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ng-monomethyl-L-arginine (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jesper N Bech, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark'}, {'name': 'Erling B Pedersen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Holstebro Hospital, 7500 Holstebro, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}}}}