Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-30 @ 5:52 PM
Study NCT ID:
NCT01609959
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2012-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521273', 'term': 'azilsartan'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-05-30', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Office Blood Pressure', 'timeFrame': 'Baseline and every 2 weeks (up to 12 weeks)', 'description': 'Change in blood pressure measured at a clinic'}], 'secondaryOutcomes': [{'measure': 'Change in Home Blood Pressure', 'timeFrame': 'Baseline and every 2 weeks (up to 12 weeks)', 'description': 'Change in blood pressure measured at home\n\nBlood pressure is measured twice daily in the morning fasting before taking any drugs.'}, {'measure': 'Change in Renal Function', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Changes in levels of serum creatinine and proteinuria'}, {'measure': 'Change in Fasting Triglyceride', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change in Glycemic Control', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)'}, {'measure': 'Change in Plasma Aldosterone Concentration', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Only in patients with secondary hypertension'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypertension', 'Angiotensin II Receptor Blocker', 'Azilsartan', 'Valsartan'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.', 'detailedDescription': 'Hypertension plays a major role in the development of cardiovascular disease. Several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor.\n\nA new angiotensin II receptor blocker (ARB), azilsartan, is the first drug which is superior to other ARBs in blood pressure lowering in phase III clinical trials in Japan. We try to evaluate effect of azilsartan on blood pressure lowering in Japanese patients with hypertension who have already taken normal-dose ARBs, and to compare it with that of valsartan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan\n* Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day.\n\nExclusion Criteria:\n\n* Hypersensitivity for azilsartan and valsartan\n* Pregnant female\n* History of azilsartan use within 3 months'}, 'identificationModule': {'nctId': 'NCT01609959', 'acronym': 'NARA', 'briefTitle': 'New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering', 'organization': {'class': 'OTHER', 'fullName': 'Nara Medical University'}, 'officialTitle': 'Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension', 'orgStudyIdInfo': {'id': '12-Ken-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azilsartan group', 'interventionNames': ['Drug: Azilsartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valsartan group', 'interventionNames': ['Drug: Valsartan']}], 'interventions': [{'name': 'Azilsartan', 'type': 'DRUG', 'description': 'Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks', 'armGroupLabels': ['Azilsartan group']}, {'name': 'Valsartan', 'type': 'DRUG', 'description': 'Valsartan 160 mg per day', 'armGroupLabels': ['Valsartan group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '634-8522', 'city': 'Kashihara', 'state': 'Nara', 'country': 'Japan', 'facility': 'First Department of Nara Medical University', 'geoPoint': {'lat': 33.95, 'lon': 135.78333}}], 'overallOfficials': [{'name': 'Yoshihiko Saito, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Department of Internal Medicine, Nara Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nara Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yoshihiko Saito', 'investigatorAffiliation': 'Nara Medical University'}}}}