Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-18 @ 7:55 PM
Study NCT ID:
NCT02893358
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2016-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antihypertensive Treatment in Masked Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059468', 'term': 'Masked Hypertension'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587132', 'term': 'allisartan isoproxil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement rate of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria)', 'timeFrame': '1 year', 'description': 'Improvement was defined as the relevant parameters (Cornell voltage combination, Sokolow-Lyon index, microalbuminuria/creatinine ratio, brachial-ankle pulse wave velocity) back to normal or declined at least 20%.'}], 'secondaryOutcomes': [{'measure': '24h ambulatory blood pressure', 'timeFrame': '1 year'}, {'measure': 'electrocardiogram', 'timeFrame': '1 year', 'description': 'calculating Cornell voltage combination and Sokolow-Lyon index'}, {'measure': 'microalbuminuria/creatinine ratio', 'timeFrame': '1 year'}, {'measure': 'brachial-ankle pulse wave velocity', 'timeFrame': '1 year'}, {'measure': 'incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction)', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allisartan Isoproxil', 'left ventricular hypertrophy', 'large arterial stiffness', 'microalbuminuria'], 'conditions': ['Masked Hypertension']}, 'referencesModule': {'references': [{'pmid': '39091669', 'type': 'DERIVED', 'citation': 'Huang JF, Zhang DY, An DW, Li MX, Liu CY, Feng YQ, Zheng QD, Chen X, Staessen JA, Wang JG, Li Y; ANTI-MASK Investigators. Efficacy of antihypertensive treatment for target organ protection in patients with masked hypertension (ANTI-MASK): a multicentre, double-blind, placebo-controlled trial. EClinicalMedicine. 2024 Jul 18;74:102736. doi: 10.1016/j.eclinm.2024.102736. eCollection 2024 Aug.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to estimate the target organ protection after 12 months of antihypertensive treatment in masked hypertension patients with at least one kind of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria). Improvement was defined as the relevant parameter back to normal or declined at least 20%.\n\nThe secondary objectives include: blood pressure lowering effect, target organ damage parameters improvement, and the incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 30-70 years old\n2. Masked hypertension patients, defined as clinic BP\\<140/90 mmHg, while 24h ambulatory BP ≥130/80 mmHg and (or) daytime BP ≥135/85 mmHg and (or) nighttime BP ≥120/70 mmHg\n3. Combined with at least one kind of target organ damage: left ventricular hypertrophy (Cornell voltage combination ≥2440mm·ms or Sokolow-Lyon index ≥4.0mv for male and 3.5mv for female), large arterial stiffness (brachial-ankle pulse wave velocity ≥1400cm/s) and microalbuminuria (twice random urine microalbuminuria/creatinine ratio ≥2.5mg/mmol for male and 3.5mg/mmol for female).\n4. Didn't use any anti-hypertension drugs within 2 weeks\n5. Be willing to participate in the trials and able to finish clinic visits\n\nExclusion Criteria:\n\n1. Under antihypertensive treatment\n2. Secondary hypertension\n3. Taking other medications that may influence BP\n4. Sleep apnea syndrome\n5. Diabetes combined with microalbuminuria\n6. Renal parenchymal disease, such as chronic nephritis, polycystic kidney\n7. Occurrence of coronary heart disease, myocardial infraction or stroke within 6 months\n8. Structural heart disease, such as hypertrophic cardiomyopathy, dilated cardiomyopathy\n9. Alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) upper the twice of normal range, serum creatinine (Scr)≥2.0mg/dl, plasma hypokalemia≥5.5mmol/L,\n10. Patients have contraindications to angiotensin receptor blockers (ARBs)"}, 'identificationModule': {'nctId': 'NCT02893358', 'acronym': 'ANTI-MASK', 'briefTitle': 'Antihypertensive Treatment in Masked Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Institute of Hypertension'}, 'officialTitle': 'Antihypertensive Treatment in Masked Hypertension for Target Organ Protection (ANTI-MASK)', 'orgStudyIdInfo': {'id': 'ANTI-MASK20160830'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active treatment', 'description': 'Treatment will be started with allisartan isoproxil 80mg once daily taken in the morning during 8:00-9:00. After 2 months, to achieve the target BP (24h BP\\<130/80 mmHg, and daytime BP \\<135/85 mmHg, and nighttime BP \\<120/70 mmHg), allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan Isoproxil.', 'interventionNames': ['Drug: Allisartan Isoproxil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets are identical to the active study drugs, with a similar schedule of administration.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Allisartan Isoproxil', 'type': 'DRUG', 'description': 'Allisartan Isoproxil 80mg once daily taken in the morning during 8:00-9:00. To achieve the target blood pressure allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan isoproxil. Duration: 12 months.', 'armGroupLabels': ['Active treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yan Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Doctor of Medicine, Doctor of Philosophy', 'investigatorFullName': 'Yan Li', 'investigatorAffiliation': 'Shanghai Institute of Hypertension'}}}}