Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00751751
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2008-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly
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': 'D000068557', 'term': 'Olmesartan Medoxomil'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'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': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-11', 'studyFirstSubmitDate': '2008-09-11', 'studyFirstSubmitQcDate': '2008-09-11', 'lastUpdatePostDateStruct': {'date': '2008-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean sitting diastolic blood pressure assessed by conventional BP measurements', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in mean sitting diastolic BP assessed by conventional BP measurements', 'timeFrame': 'after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks'}, {'measure': 'Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP', 'timeFrame': 'after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years or older\n* Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP \\>=150 mm HG\n\nExclusion Criteria:\n\n* Secondary hypertension\n* Malignant hypertension\n* Severe heart failure (NYHA III-IV)\n* History or evidence of renal disease\n* Recent history of myocardial infarction\n* Hypersensitivity to study drugs\n* History of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00751751', 'briefTitle': 'Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.', 'orgStudyIdInfo': {'id': 'SE-866/36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'oral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks', 'interventionNames': ['Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP.', 'interventionNames': ['Drug: losartan + hydrochlorothiazide, if necessary']}], 'interventions': [{'name': 'olmesartan medoxomil + hydrochlorothiazide, if necessary', 'type': 'DRUG', 'description': 'oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP', 'armGroupLabels': ['1']}, {'name': 'losartan + hydrochlorothiazide, if necessary', 'type': 'DRUG', 'description': 'oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tablets, after 12 weeks, if needed to control BP.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Darmstadt', 'country': 'Germany', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}], 'overallOfficials': [{'name': 'Peter U Witte, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMFORM GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Petra Laeis, Ph.D.', 'oldOrganization': 'Daiichi Sankyo Europe, GmbH'}}}}