Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 7:50 AM
Study NCT ID:
NCT01028534
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437965', 'term': 'olmesartan'}, {'id': 'C061679', 'term': 'azelnidipine'}, {'id': 'D057911', 'term': 'Angiotensin Receptor Antagonists'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-01', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Six months'}], 'secondaryOutcomes': [{'measure': 'Oxygen desaturation index', 'timeFrame': 'Six months'}, {'measure': 'Pulse rate', 'timeFrame': 'Six months'}, {'measure': 'Endothelial dysfunction', 'timeFrame': 'Six months'}, {'measure': 'Sleep quality and sleepiness', 'timeFrame': 'Six months'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Continuous positive pressure ventilation', 'Blood pressure', 'Oxygen desaturation index', 'Endothelial dysfunction', 'Patient reported measurement'], 'conditions': ['Obstructive Sleep Apnea', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.', 'detailedDescription': 'Obstructive sleep apnea (OSA) and hypertension have a significant interrelationship, and both disorders are well known risk factors for cardiovascular diseases (CVD). Treating them appropriately may improve the prognosis of the patients. Presently, continuous positive airway pressure (CPAP) therapy is the first-line therapy for OSA, and angiotensin II receptor blockers and long-acting calcium channel blockers for hypertension in Japan. Therefore, in the present study, we wanted to compare the effects of these different types of antihypertensive drugs on the control of blood pressure in patients with OSA whose hypertension is not controlled well after CPAP therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apnea and hypopnea index of more than 20 /hr, and treated with CPAP\n* Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg\n\nExclusion Criteria:\n\n* Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months\n* Uncontrolled arrhythmia\n* Severe hepatic or renal disorders\n* Having poor prognosis disorders such as malignant disorders'}, 'identificationModule': {'nctId': 'NCT01028534', 'briefTitle': 'Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University, Graduate School of Medicine'}, 'officialTitle': 'Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'C359kyoto'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ARB plus increased ARB', 'description': 'angiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months', 'interventionNames': ['Drug: Olmesartan and Azelnidipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ARB plus CCB', 'description': 'angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months', 'interventionNames': ['Drug: Olmesartan and Azelnidipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CCB plus ARB', 'description': 'calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months', 'interventionNames': ['Drug: Olmesartan and Azelnidipine']}], 'interventions': [{'name': 'Olmesartan and Azelnidipine', 'type': 'DRUG', 'otherNames': ['Olmesartan (angiotensin II receptor blockers: ARB)', 'Azelnidipine (long-acting calcium channel blockers: CCB)'], 'description': '1. Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 3 months\n2. Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months\n3. Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months', 'armGroupLabels': ['ARB plus CCB', 'ARB plus increased ARB', 'CCB plus ARB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kitakyushu', 'country': 'Japan', 'facility': 'Kirigaoka Tsuda Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Kazuo Chin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Graduate School of Medicine, Kyoto University'}, {'name': 'Toru Oga, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Graduate School of Medicine, Kyoto University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto University, Graduate School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine', 'investigatorFullName': 'Toru Oga', 'investigatorAffiliation': 'Kyoto University, Graduate School of Medicine'}}}}