Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 4:53 AM
Study NCT ID:
NCT00200694
Status:
TERMINATED
Last Update Posted:
2009-02-04
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017257', 'term': 'Ramipril'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 18}}, 'statusModule': {'whyStopped': "difficulty in patients's inclusion", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Proteinuria', 'ACEI', 'ARB', 'diuretics', 'blood pressure', 'renal failure'], 'conditions': ['Heavy Proteinuria']}, 'descriptionModule': {'briefSummary': 'Determine the best strategy for proteinuria lowering in patients with proteinuria \\> 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proteinuria \\> 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months\n* proteinuria changes \\< 50% on 3 separate dosages over 2 months.\n\nExclusion criteria:\n\n* age \\< 18 or \\> 80 years systolic BP \\< 110 or ≥ 140 mmHg, serum creatinine \\> 250 mmole/L\n* serum creatinine increase on ramipril + valsartan \\> 20%\n* intolerance to ACEI or ARB'}, 'identificationModule': {'nctId': 'NCT00200694', 'briefTitle': 'Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'orgStudyIdInfo': {'id': 'BRD 03-5-D'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ramipril 5 mg + valsartan 80 mg/day,', 'type': 'DRUG'}, {'name': 'ramipril 10 mg + valsartan 160 mg/day,', 'type': 'DRUG'}, {'name': 'ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Vincent LM Esnault, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}}}}