[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100086672":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":26,"locations":39,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Core Treatment","EXPERIMENTAL","Oral pills of aliskiren 150 mg \u002Fvalsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg \u002Fvalsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and\u002For mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.",[13,14],"Drug: Aliskiren","Drug: Valsartan",{"label":16,"type":10,"description":17,"interventionNames":18},"Extension Treatment","For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg\u002Fvalsartan 320 mg were treated with aliskiren 300 mg\u002Fvalsartan 320 mg\u002FHCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg\u002Fvalsartan 320 mg\u002FHCTZ 12.5 mg.\n\nThe HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and\u002For the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.",[13,14,19],"Drug: Hydrochlorothiazide (HCTZ)",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Aliskiren","Aliskiren 300 mg",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Valsartan","Valsartan 320 mg",[9,16],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Hydrochlorothiazide (HCTZ)","Hydrochlorothiazide (HCTZ) 12.5-25 mg",[16],[36],{"name":37,"affiliation":37,"role":38},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[40,52,55,58],{"facility":41,"status":26,"city":42,"state":43,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":26},"Investigative Centers","San Diego","California","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.16472,32.71571,{"lat":50,"lon":49},{"facility":41,"status":26,"city":53,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Canada","CA",{"facility":41,"status":26,"city":56,"state":26,"zip":26,"country":56,"countryCode":57,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Germany","DE",{"facility":41,"status":26,"city":59,"state":26,"zip":26,"country":59,"countryCode":60,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Netherlands","NL",{"type":26,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":62,"oldOrganization":5},"External Affairs","100086672","phase-3-a-safety-and-tolerability-study-of-the-combination-of-aliskirenvalsartan-in-patients-with-high-blood-pressure-followed-by-long-term-safety-and-tolerability-of-aliskiren-valsartan-and-hydrochlorothiazide-100086672",true,"NCT00386607","A Safety and Tolerability Study of the Combination of Aliskiren\u002FValsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.","A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg \u002FValsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren\u002FValsartan\u002FHydrochlorothiazide(HCTZ)","Inclusion Criteria: -\n\n* Male and female outpatients 18 years of age and older.\n* For newly diagnosed\u002Funtreated patients with essential hypertension defined as msDBP ≥ 90 and \\\u003C 110 mmHg at Visit 1 and Visit 4\n* For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \\\u003C 110 mmHg after 2 to 4 weeks of washout (Visit 4)\n* Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).\n\nExclusion Criteria:\n\n* Severe hypertension (msDBP ≥ 110 mmHg and\u002For msSBP ≥ 180 mmHg)\n* Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.\n* History or evidence of a secondary form of hypertension.\n* History of hypertensive encephalopathy or cerebrovascular accident.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",false,"ALL","18 Years",{"count":74,"type":75},601,"ACTUAL","INTERVENTIONAL",[78],"PHASE3","Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg\u002F 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren\u002Fvalsartan\u002FHydrochlorothiazide(HCTZ).",[81],"Hypertension",[83],"Hypertension, aliskiren, valsartan, HCTZ, blood pressure","COMPLETED","2014-01-14",{"date":87,"type":88},"2014-02-10","ESTIMATED",{"date":90,"type":26},"2006-10",{"date":92,"type":75},"2008-07",{"name":5,"class":6},4]