Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-09 @ 7:04 AM
Study NCT ID:
NCT00362960
Status:
COMPLETED
Last Update Posted:
2006-10-09
First Post:
2006-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olmesartan Medoxomil and Diabetic Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}, {'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2004-09'}, 'lastUpdateSubmitDate': '2006-10-06', 'studyFirstSubmitDate': '2006-08-10', 'studyFirstSubmitQcDate': '2006-08-11', 'lastUpdatePostDateStruct': {'date': '2006-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of olmesartan medoxomil doses compared to losartan in'}, {'measure': 'patients with type 2 diabetes and nephropathy in terms of the change in'}, {'measure': 'proteinuria (total urinary protein excretion) from baseline.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of the treatment with olmesartan medoxomil dosages compared to'}, {'measure': 'losartan in patients with type 2 diabetes and nephropathy in terms of'}, {'measure': 'change in:'}, {'measure': 'creatinine clearance (CLCR)'}, {'measure': 'the protein pattern (nephelometry)'}, {'measure': 'inflammatory markers (circulating serum markers).'}, {'measure': 'Evaluate safety and tolerability of all treatments.'}]}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Diabetic Nephropathy', 'Inflammatory Markers', 'Proteinuria', 'Renal Disease'], 'conditions': ['Type 2 Diabetes Mellitus', 'Diabetic Nephropathy', 'Proteinuria', 'Renal Disease']}, 'descriptionModule': {'briefSummary': 'Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female European out-patients\n* Greater than or equal to 30 years of age\n* Type 2 diabetes first diagnosed at greater than or equal to 30 years of age\n* Urinary protein excretion between 200-4000 mg/day exclusive\n* Mean sitting dBP less than or equal to 110 mgHg\n* Medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary\n\nExclusion Criteria:\n\n* Females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception\n* Secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dBP exceeding 110 mmHg or sitting sBP exceeding 200 mmHg\n* ECG evidence of 2nd or 3rd degree AV-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia\n* Presence of significant cardiovascular disease\n* Significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease\n* Concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dL or creatinine clearance CLCR less than or equal to 50 mL/min\n* Clinically significant lab abnormalities (ASAT/SGOT, ALAT/SGPT and γ-GT )\n* Serum potassium level \\< 2.5 mmol/L or \\> 5.5 mmol/L\n* Treatment of concurrent indications with drugs or medication which could have influenced BP\n* History of hypersensitivity, lack of response or contraindication to Ang II-antagonists, HCTZ or atenolol, or hypersensitivity to related drugs (cross-allergy)'}, 'identificationModule': {'nctId': 'NCT00362960', 'briefTitle': 'Olmesartan Medoxomil and Diabetic Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy', 'orgStudyIdInfo': {'id': 'SE-866/29'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Olmesartan medoxomil', 'type': 'DRUG'}, {'name': 'Losartan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frýdlant', 'country': 'Czechia', 'geoPoint': {'lat': 50.92139, 'lon': 15.07974}}, {'city': 'Liberec', 'country': 'Czechia', 'geoPoint': {'lat': 50.76711, 'lon': 15.05619}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Tartu', 'country': 'Estonia', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Augsburg', 'country': 'Germany', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Greifenstein-Beilstein', 'country': 'Germany'}, {'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Zwijndrecht', 'country': 'Netherlands', 'geoPoint': {'lat': 51.8175, 'lon': 4.63333}}, {'city': 'Grodzisk Mazowiecki', 'country': 'Poland', 'geoPoint': {'lat': 52.10387, 'lon': 20.6337}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Pruszków', 'country': 'Poland', 'geoPoint': {'lat': 52.17072, 'lon': 20.81214}}, {'city': 'Płock', 'country': 'Poland', 'geoPoint': {'lat': 52.54682, 'lon': 19.70638}}, {'city': 'Torun', 'country': 'Poland', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Watlack', 'country': 'Poland'}, {'city': 'Wołomin', 'country': 'Poland', 'geoPoint': {'lat': 52.34006, 'lon': 21.24207}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Banská Bystrica', 'country': 'Slovakia', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'city': 'Košice', 'country': 'Slovakia', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'city': 'Lučenec', 'country': 'Slovakia', 'geoPoint': {'lat': 48.33249, 'lon': 19.66708}}, {'city': 'Martin', 'country': 'Slovakia', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'city': 'Nitra', 'country': 'Slovakia', 'geoPoint': {'lat': 48.30763, 'lon': 18.08453}}, {'city': 'Nové Zámky', 'country': 'Slovakia', 'geoPoint': {'lat': 47.98544, 'lon': 18.16195}}, {'city': 'Šahy', 'country': 'Slovakia', 'geoPoint': {'lat': 48.07408, 'lon': 18.94946}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'H Haller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sankyo Pharma Gmbh', 'class': 'INDUSTRY'}}}}