[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100259095":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":28,"centralContacts":28,"locations":36,"responsibleParty":47,"collaborators":28,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":28,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":28,"enrollmentInfo":58,"targetDuration":28,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":68,"whyStopped":28,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Chong Kun Dang Pharmaceutical","INDUSTRY",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Candesartan 16mg + Amlodipine 5mg","EXPERIMENTAL","Candesartan 16mg + Amlodipine 5mg, po, q.d.",[13,14],"Drug: Candesartan 16mg","Drug: Amlodipine 5mg",{"label":16,"type":10,"description":17,"interventionNames":18},"Candesartan 16mg + Amlodipine 10mg","Candesartan 16mg + Amlodipine 10mg, po, q.d.",[13,19],"Drug: Amlodipine 10mg",{"label":21,"type":22,"description":23,"interventionNames":24},"Candesartan 16mg","ACTIVE_COMPARATOR","Candesartan 16mg, po, q.d.",[13],[26,30,33],{"type":27,"name":21,"description":28,"armGroupLabels":29,"otherNames":28},"DRUG",null,[21,16,9],{"type":27,"name":31,"description":28,"armGroupLabels":32,"otherNames":28},"Amlodipine 5mg",[9],{"type":27,"name":34,"description":28,"armGroupLabels":35,"otherNames":28},"Amlodipine 10mg",[16],[37],{"facility":38,"status":28,"city":39,"state":28,"zip":28,"country":40,"countryCode":28,"cosmosGeoPoint":41,"geoPoint":46,"contacts":28},"Severance Hospital","Seoul","South Korea",{"type":42,"coordinates":43},"Point",[44,45],126.9784,37.566,{"lat":45,"lon":44},{"type":48,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100259095","phase-3-trial-to-evaluate-the-efficacy-and-safety-of-a-combination-therapy-of-candesartan-and-amlodipine-versus-candesartan-monotherapy-in-hypertensive-patients-inadequately-controlled-by-candesartan-monotherapy-100259095",false,"NCT02651870","Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy","A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy","Inclusion Criteria:\n\n* Age of 19 or above\n* Inadequately controlled Essential hypertension at Screening\n\n  1. Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1\n\n     * Mean sitDBP ≥ 95mmHg on target arm\n  2. Taking antihypertensive drug but not controlled\n\n     * Mean sitDBP ≥ 90mmHg on target arm\n* Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy\n\n  * Mean sitDBP at Visit 2 ≥ 90mmHg on target arm\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1\n* Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2\n* Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)\n* Patient with congestive heart failure(NYHA class III, IV)\n* Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months\n* History of stroke, cerebral hemorrhage within 6 months\n* Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c \\> 8.5%\n* History of severe or malignant retinopathy\n* AST\u002FALT \\> UNL\\*3, Serum creatinine \\> UNL\\*1.5, K \\> 5.5mEq\u002FL\n* Patient with acute or chronic inflammatory(treatment required) status\n* Patient who need to take antihypertensive drug besides Investigational products\n* Patient must be treated with medications prohibited for concomitant use during the study period\n* History of angioedema related to ACE inhibitor or angiotensin II receptor blockers\n* Hypersensitive to Candesartan\u002FAmlodipine\n* Patient who are dependent on drugs or alcohol within 6 months\n* History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract\n* Patients treated with other investigational product within 30 days at first time taking the investigational product\n* Women with pregnant, breast-feeding\n* History of malignant tumor within 5 years\n* Not eligible to participate for the study at the discretion of investigator","ALL","19 Years",{"count":59,"type":60},135,"ACTUAL","INTERVENTIONAL",[63],"PHASE3","A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy",[66],"Hypertension",[66],"COMPLETED","2020-08-23",{"date":71,"type":60},"2020-08-25",{"date":73,"type":60},"2015-04-22",{"date":75,"type":60},"2016-02-29",{"name":5,"class":6},1]