[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100306063":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":49,"responsibleParty":73,"collaborators":39,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":39,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":39,"overallStatus":52,"whyStopped":39,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Guangdong Provincial People's Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"intensive treatment group","ACTIVE_COMPARATOR","Real antihypertensive agents will be provided for this arm, to decrease systolic BP to lower than 120 mm Hg. In this group, the following study medications will be used: tablets with Allisartan Isoproxil 240 mg (first-line medication); tablets with Amlodipine 5 mg (second-line medication). Treatment will be started with Allisartan 240 mg. If necessary to reach the BP goal, Amlodipine (first 5 mg or then 10 mg daily) will be given in addition. If intolerable side effects occur, first-line medication may be replaced by second-line medication.",[13,14],"Drug: Allisartan Isoproxil","Drug: Amlodipine 5mg",{"label":16,"type":17,"description":18,"interventionNames":19},"standard treatment group","PLACEBO_COMPARATOR","In this arm participants are followed up and no medications be used until BP becomes ≥ 140 mm Hg systolic and\u002For 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic.",[20],"Other: Standard treatment by current guideline",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Allisartan Isoproxil","Allisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic.",[9],[28],"Xinlitan",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Amlodipine 5mg","Amlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic).",[9],[34],"Qiaohean",{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Standard treatment by current guideline","No BP-lowering medications are used until BP becomes ≥ 140 mm Hg systolic and\u002For 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic.",[16],null,[41],{"name":42,"affiliation":5,"role":43},"Jiyan Chen, MD","PRINCIPAL_INVESTIGATOR",[45],{"name":42,"role":46,"phone":47,"phoneExt":39,"email":48},"CONTACT","86-13802911148","chen-jiyan@163.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Guangdong General Hospital","RECRUITING","Guangzhou","Guangdong","501080","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},[65,69],{"name":66,"role":46,"phone":67,"phoneExt":39,"email":68},"Yingqing Feng, MD","86-13602863389","fyq1819@163.com",{"name":70,"role":46,"phone":71,"phoneExt":39,"email":72},"Qi Zhong, MD","86-13580366163","zhongqi219@126.com",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"SPONSOR_INVESTIGATOR","XueQing Yu","Director of the Guangdong Provincial People's Hospital","100306063","phase-4-intervention-for-high-normal-blood-pressure-in-adults-with-type-2-diabetes-100306063",false,"NCT03264352","Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes","IPAD","Inclusion Criteria:\n\n* irrespective of sex;\n* aged between 45 and 79 years;\n* with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;\n* diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;\n* informed consent provided and long-term follow-up possible\n\nExclusion Criteria:\n\n* poor control of blood glucose, HbA1c \\> 10.0%\n* administration of any antihypertensive medications within 1 month;\n* a history of hypoglycemic coma \u002F seizure;\n* confirmed diagnosis of type 1 diabetes mellitus;\n* alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;\n* estimated glomerular filtration rate \\\u003C 45 ml\u002Fmin\u002F1.73m2;\n* a history of congestive heart failure with left ventricular ejection fraction \\\u003C 40%;\n* coronary artery disease requiring RAS blockers for secondary prevention;\n* acute on-set of stroke within 6 months prior to randomization;\n* a ratio of urinary albumin (in mg\u002FL) to urinary creatinine (in g\u002FL) (ACR) ≥ 300 mg\u002Fg;\n* known contraindications for the active study medications;\n* a history of psychological or mental disorder;\n* pregnancy or currently planning to have babies or lactation;\n* severe diseases such as severe heart diseases;\n* an expected residual life span less than 3 years;\n* a malignancy that clinical investigators consider as unsuitable to participate;\n* currently participating in another clinical trial.","ALL","45 Years","79 Years",{"count":88,"type":89},11414,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg\u002Fday), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg\u002Fday), and\u002For other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.",[95,96,97,98,99],"Diabetes Mellitus, Type 2","Adverse Event","Blood Pressure","Prehypertension","Cardiovascular Risk Factor","2025-03-10",{"date":102,"type":103},"2025-03-12","ACTUAL",{"date":105,"type":103},"2018-02-01",{"date":107,"type":89},"2025-09",{"name":75,"class":6},1]