Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-03-30 @ 6:50 AM
Study NCT ID:
NCT00185068
Status:
COMPLETED
Last Update Posted:
2005-09-16
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000092244', 'term': 'Isolated Systolic Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2004-10'}, 'lastUpdateSubmitDate': '2005-09-09', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean trough seated systolic blood pressure compared to the start of the study'}], 'secondaryOutcomes': [{'measure': '1. Blood pressure changes from baseline at the end of each titration period.'}, {'measure': '2. Percentage of patients responding to therapy'}, {'measure': '3. Percentage of patients achieving various blood pressure target goals'}]}, 'conditionsModule': {'keywords': ['Systolic hypertension, Angiotensin receptor blocker'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. 18 years of age.\n* 2\\. Patients with stage II systolic hypertension\n* 3\\. If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.\n\nExclusion Criteria:\n\n* 1\\. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.\n\n 2\\. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.\n\n 3\\. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP \\> 200 mm Hg).\n\n 4\\. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.\n\n 5\\. Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.\n\n 7\\. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.\n\n 8\\. Laboratory test values considered clinically significant by the investigator.\n\n 9\\. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin \\> 3 times the upper limit of normal.\n\n 10\\. Pregnant or lactating females.\n* 11\\. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin."}, 'identificationModule': {'nctId': 'NCT00185068', 'briefTitle': 'An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension', 'orgStudyIdInfo': {'id': '866-443'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Olmesartan medoxomil', 'type': 'DRUG'}, {'name': 'Olmesartan medoxomil/hydrochlorothiazide', 'type': 'DRUG'}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fort Lauderdale', 'state': 'California', 'country': 'United States'}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Roseville', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Santa Anna', 'state': 'California', 'country': 'United States'}, {'city': 'Tustin', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Orland Park', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.63031, 'lon': -87.85394}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}}}}