[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100120999":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":25,"locations":31,"responsibleParty":87,"collaborators":25,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":25,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":25,"enrollmentInfo":99,"targetDuration":25,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":114,"whyStopped":25,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aliskiren\u002Famlodipine 300\u002F10 mg tablet","EXPERIMENTAL","Aliskiren\u002Famlodipine treatment regimen: At randomization, patients were treated with aliskiren\u002Famlodipine 150\u002F5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren\u002Famlodipine 300\u002F10 mg.",[13],"Drug: Aliskiren\u002Famlodipine 300\u002F10 mg tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Amlodipine 10 mg capsule","ACTIVE_COMPARATOR","Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.",[19],"Drug: Amlodipine 10 mg capsule",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office\u002Fclinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":5,"affiliation":5,"role":30},"STUDY_DIRECTOR",[32,43,52,61,70,78],{"facility":33,"status":25,"city":34,"state":25,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":25},"Investigative Site","Berlin","Germany","DE",{"type":38,"coordinates":39},"Point",[40,41],13.41053,52.52437,{"lat":41,"lon":40},{"facility":33,"status":25,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":51,"contacts":25},"Manila","Philippines","PH",{"type":38,"coordinates":48},[49,50],120.9822,14.6042,{"lat":50,"lon":49},{"facility":33,"status":25,"city":53,"state":25,"zip":25,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":60,"contacts":25},"Bucharest","Romania","RO",{"type":38,"coordinates":57},[58,59],26.10626,44.43225,{"lat":59,"lon":58},{"facility":33,"status":25,"city":62,"state":25,"zip":25,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":25},"Moscow","Russia","RU",{"type":38,"coordinates":66},[67,68],37.61781,55.75204,{"lat":68,"lon":67},{"facility":33,"status":25,"city":71,"state":25,"zip":25,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":25},"Singapore","SG",{"type":38,"coordinates":74},[75,76],103.85007,1.28967,{"lat":76,"lon":75},{"facility":33,"status":25,"city":79,"state":25,"zip":25,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":25},"Madrid","Spain","ES",{"type":38,"coordinates":83},[84,85],-3.70256,40.4165,{"lat":85,"lon":84},{"type":25,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":88,"oldOrganization":5},"External Affairs","100120999","phase-3-efficacy-and-safety-of-the-combination-of-aliskiren-300-mg-and-amlodipine-10-mg-compared-to-amlodipine-10-mg-monotherapy-in-patients-with-moderate-to-severe-hypertension-100120999",true,"NCT00841672","Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension","An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients","Inclusion Criteria:\n\n* Outpatients ≥ 18 years of age\n* Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and \\\u003C 200 mmHg at Visit 2\n\nExclusion Criteria:\n\n* Mild to moderate hypertension\n* Pregnant or nursing (lactating) women\n* Women of child-bearing potential\n* Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV.\n* Serum potassium ≥ 5.3 mEq\u002FL (mmol\u002FL) at Visit 1.\n* Uncontrolled Type 1 or Type 2 diabetes mellitus\n* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures\n* History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention\n* Patients on a combination of 3 or more antihypertensive medications\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",false,"ALL","18 Years",{"count":100,"type":101},485,"ACTUAL","INTERVENTIONAL",[104],"PHASE3","This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren\u002Famlodipine 300\u002F10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren\u002Famlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.",[107],"Moderate to Severe Hypertension",[109,110,111,112,113],"Hypertension","systolic blood pressure","cardiovascular disease","aliskiren","amlodipine","COMPLETED","2011-07-05",{"date":117,"type":118},"2011-07-12","ESTIMATED",{"date":120,"type":25},"2009-01",{"date":122,"type":101},"2009-09",{"name":5,"class":6},6]