Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
Study NCT ID:
NCT00571766
Status:
COMPLETED
Last Update Posted:
2009-09-10
First Post:
2007-12-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-09', 'studyFirstSubmitDate': '2007-12-11', 'studyFirstSubmitQcDate': '2007-12-11', 'lastUpdatePostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate blood pressure changes in pregnant women with chronic hypertension during oral arginine or placebo treatment in second trimester of gestation.', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate if is necessary add a conventional therapy for hypertension, to evaluate the maternal and fetal outcomes and possible complications, to evaluate the safety of L-Arginine.', 'timeFrame': '14 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic hypertension in pregnancy', 'chronic Hypertension'], 'conditions': ['Hypertension in Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of oral L-Arginine in pregnant women with chronic hypertension.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 18-20 week of gestation with chronic hypertension\n\nExclusion Criteria:\n\n* Maternal or fetal disease'}, 'identificationModule': {'nctId': 'NCT00571766', 'briefTitle': 'Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy', 'orgStudyIdInfo': {'id': 'Oral L-Arginine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Oral L-Arginine 2 g twice a day for 14 weeks', 'interventionNames': ['Drug: L-Arginine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo 2 g, twice a day for 14 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'L-Arginine', 'type': 'DRUG', 'description': 'Oral L-Arginine 2g, twice a day for 14 weeks', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 2 g twice a day for 14 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Modena', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'University of Modena and Reggio Emilia', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'Fabio Facchinetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Modena and Reggio Emilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fabio Facchinetti', 'oldOrganization': 'University of Modena and Reggio Emilia'}}}}