{"id":"valsartan-amlodipine","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Peripheral edema"},{"rate":"3-7","effect":"Dizziness"},{"rate":"2-5","effect":"Fatigue"},{"rate":"2-4","effect":"Headache"},{"rate":"1-3","effect":"Hyperkalemia"},{"rate":"1-2","effect":"Cough"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a fixed-dose combination of two antihypertensive agents with complementary mechanisms. Valsartan is an angiotensin II receptor blocker (ARB) that prevents vasoconstriction and aldosterone release, reducing blood pressure and cardiac strain. Amlodipine is a dihydropyridine calcium channel blocker that causes vasodilation by inhibiting calcium influx into vascular smooth muscle cells. Together, they provide synergistic blood pressure reduction.","oneSentence":"Valsartan blocks angiotensin II receptors to lower blood pressure, while amlodipine blocks calcium channels to relax blood vessels and reduce cardiac workload.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:36:41.849Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypertension"},{"name":"Hypertension in patients not adequately controlled on monotherapy"}]},"trialDetails":[{"nctId":"NCT07458880","phase":"NA","title":"Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control","status":"RECRUITING","sponsor":"The University of Hong Kong","startDate":"2026-03-01","conditions":"Intracerebral Hemorrhage","enrollment":140},{"nctId":"NCT05609513","phase":"NA","title":"Integration of Hypertension Management in HIV Care in Uganda","status":"COMPLETED","sponsor":"Infectious Diseases Research Collaboration, Uganda","startDate":"2023-02-06","conditions":"HIV/AIDS, Hypertension","enrollment":87421},{"nctId":"NCT06236061","phase":"PHASE3","title":"Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2024-04-08","conditions":"Hypertension","enrollment":718},{"nctId":"NCT07327749","phase":"PHASE4","title":"Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension","status":"COMPLETED","sponsor":"Shiraz University of Medical Sciences","startDate":"2022-10-01","conditions":"Hypertension","enrollment":59},{"nctId":"NCT07262710","phase":"","title":"Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study","status":"NOT_YET_RECRUITING","sponsor":"First Teaching Hospital of Tianjin University of Traditional Chinese Medicine","startDate":"2025-12-01","conditions":"Post-stroke Pneumonia","enrollment":13656},{"nctId":"NCT07241338","phase":"PHASE4","title":"Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity","status":"NOT_YET_RECRUITING","sponsor":"Jing Liu","startDate":"2025-11","conditions":"Hypertension","enrollment":104},{"nctId":"NCT07116863","phase":"PHASE3","title":"A Multicenter, Randomized, Double-Blind Phase 3 Trial of KDF1901 in Patients With Essential Hypertension","status":"COMPLETED","sponsor":"Kyungdong Pharmaceutical Co., Ltd.","startDate":"2022-06-21","conditions":"Essential Hypertension","enrollment":286},{"nctId":"NCT03938389","phase":"PHASE4","title":"The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ohio State University","startDate":"2020-02-25","conditions":"PreDiabetes, Impaired Glucose Tolerance, Obesity","enrollment":90},{"nctId":"NCT03476616","phase":"PHASE4","title":"Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients","status":"COMPLETED","sponsor":"Hippocration General Hospital","startDate":"2018-09-01","conditions":"Hypertension, Obesity","enrollment":198},{"nctId":"NCT05920005","phase":"PHASE3","title":"Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension","status":"COMPLETED","sponsor":"Hospital Israelita Albert Einstein","startDate":"2023-08-22","conditions":"Hypertension","enrollment":702},{"nctId":"NCT03553810","phase":"PHASE2","title":"Role of ARNi in Ventricular Remodeling in Hypertensive LVH","status":"COMPLETED","sponsor":"National Heart Centre Singapore","startDate":"2019-04-12","conditions":"Hypertensive Heart Disease","enrollment":80},{"nctId":"NCT06625346","phase":"","title":"Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients.","status":"RECRUITING","sponsor":"The Searle Company Limited Pakistan","startDate":"2024-09-28","conditions":"Hypertension","enrollment":420},{"nctId":"NCT05155137","phase":"PHASE3","title":"Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)","status":"RECRUITING","sponsor":"Hospital Moinhos de Vento","startDate":"2021-12-20","conditions":"Stroke, Cognitive Decline","enrollment":8518},{"nctId":"NCT06771245","phase":"PHASE3","title":"A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients","status":"NOT_YET_RECRUITING","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2025-01-24","conditions":"Mild-to-moderate Essential Hypertension","enrollment":606},{"nctId":"NCT06515678","phase":"","title":"Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension","status":"ACTIVE_NOT_RECRUITING","sponsor":"Groupe Hospitalier Pitie-Salpetriere","startDate":"2024-05-20","conditions":"Ovarian Cancer, Antiangiogenic-Associated Hypertension, Adjuvant Bevacizumab","enrollment":9464},{"nctId":"NCT06487949","phase":"PHASE4","title":"Valsartan and Amlodipine in Blood Pressure Management: Fixed-Dose vs. Free Drug Therapy","status":"COMPLETED","sponsor":"Shiraz University of Medical Sciences","startDate":"2022-12-01","conditions":"Hypertension","enrollment":114},{"nctId":"NCT06395194","phase":"PHASE3","title":"Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension","status":"COMPLETED","sponsor":"Oslo University Hospital","startDate":"1997-09-27","conditions":"Essential Hypertension","enrollment":15313},{"nctId":"NCT05899920","phase":"NA","title":"Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy","status":"RECRUITING","sponsor":"Ryazan State Medical University","startDate":"2022-03-11","conditions":"Resistant Arterial Hypertension","enrollment":190},{"nctId":"NCT06193044","phase":"PHASE1","title":"Bioequivalence Study of Amlodipine/Valsartan 10/160 mg Film Coated Tablets","status":"UNKNOWN","sponsor":"International Bio service","startDate":"2024-05-07","conditions":"Healthy Volunteer","enrollment":48},{"nctId":"NCT00171002","phase":"PHASE3","title":"Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-11","conditions":"Hypertension","enrollment":936},{"nctId":"NCT00170976","phase":"PHASE3","title":"A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-04","conditions":"HYPERTENSION","enrollment":403},{"nctId":"NCT00409760","phase":"PHASE3","title":"Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension.","status":"COMPLETED","sponsor":"Novartis","startDate":"2003-01","conditions":"Hypertension","enrollment":1930},{"nctId":"NCT04929600","phase":"PHASE4","title":"Sacubitril/Valsartan Versus Amlodipine in Hypertension and Left Ventricular Hypertrophy.","status":"UNKNOWN","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2021-11-28","conditions":"Hypertension, Left Ventricular Hypertrophy","enrollment":120},{"nctId":"NCT05545059","phase":"PHASE3","title":"Effects and Safety of Sacubitril/Valsartan on Refractory Hypertension","status":"UNKNOWN","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2022-09-24","conditions":"Resistant Hypertension","enrollment":138},{"nctId":"NCT02130687","phase":"NA","title":"Effect of Chronic ACE and DPP4 Inhibition on Blood Pressure","status":"COMPLETED","sponsor":"Vanderbilt University","startDate":"2014-06","conditions":"Type 2 Diabetes Mellitus, Hypertension","enrollment":106},{"nctId":"NCT05259020","phase":"PHASE1","title":"To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers","status":"UNKNOWN","sponsor":"IlDong Pharmaceutical Co Ltd","startDate":"2022-02-22","conditions":"Dyslipidemias, Hypertension","enrollment":60},{"nctId":"NCT05212597","phase":"PHASE2","title":"Open Label RCT for Chronic Severe AR : Entresto vs. CCB/ARB","status":"UNKNOWN","sponsor":"Samsung Medical Center","startDate":"2022-01-12","conditions":"Aortic Valve Insufficiency","enrollment":100},{"nctId":"NCT05077475","phase":"PHASE1","title":"A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52L in Healthy Volunteers","status":"UNKNOWN","sponsor":"AJU Pharm Co., Ltd.","startDate":"2021-09-24","conditions":"Hypertension","enrollment":60},{"nctId":"NCT05077462","phase":"PHASE1","title":"A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52H in Healthy Volunteers","status":"UNKNOWN","sponsor":"AJU Pharm Co., Ltd.","startDate":"2021-09-17","conditions":"Hypertension","enrollment":60},{"nctId":"NCT04191681","phase":"PHASE4","title":"Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study","status":"RECRUITING","sponsor":"The Cleveland Clinic","startDate":"2019-11-08","conditions":"Stage D Heart Failure","enrollment":50},{"nctId":"NCT04467931","phase":"","title":"ACEI or ARB and COVID-19 Severity and Mortality in US Veterans","status":"COMPLETED","sponsor":"University of Utah","startDate":"2020-01-19","conditions":"Hypertension, COVID","enrollment":22213},{"nctId":"NCT01870739","phase":"PHASE2","title":"A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2013-10","conditions":"Hypertension","enrollment":115},{"nctId":"NCT04686643","phase":"PHASE3","title":"Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension","status":"UNKNOWN","sponsor":"Ahn-Gook Pharmaceuticals Co.,Ltd","startDate":"2021-02-01","conditions":"Hypertension","enrollment":306},{"nctId":"NCT00523744","phase":"PHASE3","title":"Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension","status":"COMPLETED","sponsor":"Novartis","startDate":"2007-07","conditions":"Hypertension","enrollment":257},{"nctId":"NCT04330300","phase":"PHASE4","title":"Coronavirus (COVID-19) ACEi/ARB Investigation","status":"SUSPENDED","sponsor":"National University of Ireland, Galway, Ireland","startDate":"2020-04-30","conditions":"Hypertension, COVID-19","enrollment":2414},{"nctId":"NCT02973035","phase":"PHASE4","title":"Amlodipine Versus Valsartan for Improvement of Diastolic Dysfunction Associated With Hypertension","status":"COMPLETED","sponsor":"Asan Medical Center","startDate":"2016-12","conditions":"Hypertension","enrollment":104},{"nctId":"NCT04185090","phase":"PHASE1","title":"To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults","status":"UNKNOWN","sponsor":"IlDong Pharmaceutical Co Ltd","startDate":"2020-02","conditions":"Hypertension, Dyslipidemias","enrollment":30},{"nctId":"NCT04085627","phase":"PHASE1","title":"A Bioequivalence Study of Valsartan / Amlodipine From Valsartan and Amlodipine Tablets (Hua Yuan Pharmaceutical LLC, China) and Valsartan and Amlodipine Tablets (Ⅰ) (Novartis Pharma Schweiz AG, Switzerland)","status":"UNKNOWN","sponsor":"Second Affiliated Hospital of Wenzhou Medical University","startDate":"2018-10-08","conditions":"Healthy","enrollment":84},{"nctId":"NCT03990480","phase":"PHASE4","title":"Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level","status":"COMPLETED","sponsor":"Damanhour University","startDate":"2018-12-01","conditions":"Hypertension","enrollment":230},{"nctId":"NCT00745953","phase":"PHASE4","title":"Regression of Fatty Heart by Valsartan Therapy","status":"WITHDRAWN","sponsor":"University of Texas Southwestern Medical Center","startDate":"2007-08","conditions":"Metabolic Syndrome, Lipotoxicity","enrollment":""},{"nctId":"NCT02058823","phase":"PHASE4","title":"Intermittent Hypoxia 2: Cardiovascular and Metabolism","status":"TERMINATED","sponsor":"University Hospital, Grenoble","startDate":"2013-08-07","conditions":"Hypoxia, Sleep Apnea, Obstructive Sleep Apnea","enrollment":12},{"nctId":"NCT03757390","phase":"PHASE1","title":"Bioequivalence Study of CJ-30060 in Healthy Volunteers","status":"UNKNOWN","sponsor":"HK inno.N Corporation","startDate":"2018-11-09","conditions":"Healthy Subjects","enrollment":52},{"nctId":"NCT03371797","phase":"","title":"Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial","status":"COMPLETED","sponsor":"PharmEvo Pvt Ltd","startDate":"2018-02-20","conditions":"Essential Hypertension","enrollment":800},{"nctId":"NCT03657472","phase":"PHASE1","title":"Bioequivalence Study of CJ-30061 in Healthy Male Volunteers","status":"COMPLETED","sponsor":"HK inno.N Corporation","startDate":"2016-09-19","conditions":"Hypertension, Hyperlipidemia","enrollment":42},{"nctId":"NCT00741585","phase":"PHASE4","title":"Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment","status":"COMPLETED","sponsor":"University of Vigo","startDate":"2008-09-01","conditions":"Essential Hypertension, Cardiovascular Disease, Stroke","enrollment":21983},{"nctId":"NCT03648333","phase":"PHASE1","title":"Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2013-12","conditions":"Healthy Male Subjects","enrollment":27},{"nctId":"NCT03639480","phase":"PHASE3","title":"Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia","status":"UNKNOWN","sponsor":"HK inno.N Corporation","startDate":"2017-10-13","conditions":"Hypertension, Hyperlipidemia","enrollment":180},{"nctId":"NCT03639493","phase":"PHASE1","title":"Bioequivalence Study of CJ-30060 in Healthy Male Volunteers","status":"COMPLETED","sponsor":"HK inno.N Corporation","startDate":"2018-04-06","conditions":"Healthy Male Subjects","enrollment":52},{"nctId":"NCT01819779","phase":"PHASE1","title":"Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2013-03","conditions":"Healthy Male Subjects","enrollment":53},{"nctId":"NCT03536598","phase":"PHASE3","title":"Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia","status":"COMPLETED","sponsor":"HK inno.N Corporation","startDate":"2016-10-14","conditions":"Hypertension With Hyperlipidemia","enrollment":203},{"nctId":"NCT01252238","phase":"NA","title":"Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance","status":"TERMINATED","sponsor":"Brigham and Women's Hospital","startDate":"2010-06","conditions":"Insulin Sensitivity, Aortic Compliance, Diastolic Function","enrollment":24},{"nctId":"NCT02069821","phase":"PHASE1","title":"Pharmacokinetic Interactions Between Amlodipine Besylate/Valsartan and Atorvastatin in Healthy Male Subjects","status":"COMPLETED","sponsor":"HK inno.N Corporation","startDate":"2014-03","conditions":"Healthy","enrollment":56},{"nctId":"NCT00367939","phase":"PHASE3","title":"Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-12","conditions":"Hypertension","enrollment":132},{"nctId":"NCT00170963","phase":"PHASE3","title":"Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-10","conditions":"Hypertension","enrollment":1018},{"nctId":"NCT00439738","phase":"PHASE4","title":"Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2006-12","conditions":"Hypertension","enrollment":412},{"nctId":"NCT02433119","phase":"PHASE4","title":"The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy","status":"COMPLETED","sponsor":"Dong-A ST Co., Ltd.","startDate":"2015-03-16","conditions":"Hypertension","enrollment":238},{"nctId":"NCT02062645","phase":"PHASE4","title":"Study of Efficacy and Safety of CVAA489 in Hypertensive Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-02","conditions":"Essential Hypertension","enrollment":115},{"nctId":"NCT00446524","phase":"PHASE3","title":"Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)","status":"COMPLETED","sponsor":"Novartis","startDate":"2007-02","conditions":"Hypertension","enrollment":403},{"nctId":"NCT00351130","phase":"PHASE4","title":"Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-06","conditions":"Hypertension","enrollment":79},{"nctId":"NCT01241487","phase":"PHASE4","title":"A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy","status":"COMPLETED","sponsor":"Novartis","startDate":"2009-02","conditions":"Primary Hypertension","enrollment":150},{"nctId":"NCT03009474","phase":"PHASE1","title":"Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers","status":"COMPLETED","sponsor":"HK inno.N Corporation","startDate":"2015-02","conditions":"Hypertension, Hyperlipidemias","enrollment":52},{"nctId":"NCT00000620","phase":"PHASE3","title":"Action to Control Cardiovascular Risk in Diabetes (ACCORD)","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"1999-09","conditions":"Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia","enrollment":10251},{"nctId":"NCT02966717","phase":"PHASE2","title":"Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD)","status":"UNKNOWN","sponsor":"Zhujiang Hospital","startDate":"2016-08","conditions":"Renal Insufficiency, Chronic, Nephrotic Syndrome","enrollment":116},{"nctId":"NCT00392262","phase":"PHASE3","title":"A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-08","conditions":"Hypertension","enrollment":224},{"nctId":"NCT00353912","phase":"PHASE3","title":"Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-06","conditions":"Hypertension","enrollment":571},{"nctId":"NCT00360178","phase":"PHASE3","title":"Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Fixed Dose Combination in Hypertensive Patients Not Controlled by the Free Combination of an Angiotensin Receptor Blocker Plus Hydrochlorothiazide","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-07","conditions":"Hypertension","enrollment":198},{"nctId":"NCT00327145","phase":"PHASE3","title":"A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-03","conditions":"Hypertension","enrollment":894},{"nctId":"NCT00350168","phase":"PHASE3","title":"Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-06","conditions":"Hypertension","enrollment":647},{"nctId":"NCT00304226","phase":"PHASE4","title":"Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-02","conditions":"Hypertension","enrollment":1288},{"nctId":"NCT00666536","phase":"PHASE4","title":"The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy","status":"COMPLETED","sponsor":"Novartis","startDate":"2008-03","conditions":"Hypertension","enrollment":728},{"nctId":"NCT01365481","phase":"PHASE3","title":"Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-08","conditions":"Hypertension, Chronic Kidney Disease","enrollment":150},{"nctId":"NCT01692301","phase":"PHASE2","title":"Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-12","conditions":"Hypertension","enrollment":454},{"nctId":"NCT02415192","phase":"","title":"Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients","status":"UNKNOWN","sponsor":"LG Life Sciences","startDate":"2014-07","conditions":"Lower Leg Edema, Orthostatic Hypertension","enrollment":2001},{"nctId":"NCT02058446","phase":"PHASE4","title":"PMS Study of Amlodipine/Valsartan for the Treatment of Hypertension","status":"COMPLETED","sponsor":"TSH Biopharm Corporation Limited","startDate":"2013-10","conditions":"Essential Hypertension","enrollment":36},{"nctId":"NCT01663233","phase":"PHASE3","title":"Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-08","conditions":"Essential Hypertension","enrollment":266},{"nctId":"NCT01256411","phase":"PHASE2","title":"A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-11","conditions":"Essential Hypertension","enrollment":341},{"nctId":"NCT01631864","phase":"PHASE2","title":"Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-10","conditions":"Hypertension, Concurrent Obesity","enrollment":98},{"nctId":"NCT02519010","phase":"PHASE1","title":"A Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)","status":"COMPLETED","sponsor":"Genuine Research Center, Egypt","startDate":"2011-03","conditions":"Healthy","enrollment":36},{"nctId":"NCT01819220","phase":"PHASE4","title":"Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2009-04","conditions":"Hypertension","enrollment":16},{"nctId":"NCT00437645","phase":"PHASE3","title":"Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-01","conditions":"Essential Hypertension","enrollment":1183},{"nctId":"NCT01865188","phase":"PHASE3","title":"Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2014-04","conditions":"Hypertension","enrollment":""},{"nctId":"NCT01030458","phase":"PHASE4","title":"Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial","status":"COMPLETED","sponsor":"KU Leuven","startDate":"2010-09","conditions":"Blood Pressure","enrollment":183},{"nctId":"NCT01432106","phase":"PHASE1","title":"The Study of Novel Dual Renin Angiotensin Aldosterone System (RAAS) Blockade; Valsartan/Aliskiren in African American Patients With Hypertension and the Metabolic Syndrome","status":"WITHDRAWN","sponsor":"University of Michigan","startDate":"2011-02","conditions":"Hypertension, Metabolic Syndrome","enrollment":""},{"nctId":"NCT01735890","phase":"PHASE1","title":"Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet","status":"COMPLETED","sponsor":"HK inno.N Corporation","startDate":"2012-09","conditions":"Healthy","enrollment":48},{"nctId":"NCT00129233","phase":"PHASE4","title":"Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance","status":"COMPLETED","sponsor":"Nagoya University","startDate":"2004-10","conditions":"Hypertension, Type 2 Diabetes Mellitus","enrollment":1150},{"nctId":"NCT01823913","phase":"PHASE1","title":"Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers","status":"COMPLETED","sponsor":"Severance Hospital","startDate":"2012-07","conditions":"Healthy","enrollment":50},{"nctId":"NCT01652339","phase":"PHASE1","title":"Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2012-07","conditions":"Healthy Male Subjects","enrollment":40},{"nctId":"NCT01368536","phase":"PHASE4","title":"Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-05","conditions":"Hypertension, Stage 2 Hypertension, Diabetes","enrollment":975},{"nctId":"NCT01776047","phase":"PHASE1","title":"A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers","status":"COMPLETED","sponsor":"Dong-A Pharmaceutical Co., Ltd.","startDate":"2012-07","conditions":"Healthy Male Volunteer","enrollment":51},{"nctId":"NCT00661895","phase":"PHASE4","title":"Black Education and Treatment of Hypertension (BEAT HTN)","status":"COMPLETED","sponsor":"Creighton University","startDate":"2005-08","conditions":"Hypertension","enrollment":99},{"nctId":"NCT00902304","phase":"PHASE4","title":"Valsartan Intensified Primary Care Reduction of Blood Pressure Study","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-07","conditions":"Hypertension","enrollment":2337},{"nctId":"NCT00518479","phase":"NA","title":"Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression","status":"COMPLETED","sponsor":"University of Leeds","startDate":"2003-09","conditions":"Hypertension, Left Ventricular Hypertrophy","enrollment":42},{"nctId":"NCT01198496","phase":"PHASE4","title":"Recurrent Stroke Prevention Clinical Outcome Study","status":"UNKNOWN","sponsor":"Biomedis International Ltd.","startDate":"2010-10","conditions":"Hypertension, Stroke, Blood Pressure","enrollment":5000},{"nctId":"NCT01167153","phase":"PHASE4","title":"Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients","status":"COMPLETED","sponsor":"Novartis","startDate":"2010-05","conditions":"Hypertension","enrollment":564},{"nctId":"NCT01494727","phase":"PHASE1","title":"Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg","status":"COMPLETED","sponsor":"HK inno.N Corporation","startDate":"2012-02","conditions":"Healthy","enrollment":48},{"nctId":"NCT00523549","phase":"PHASE4","title":"The Effects of Systolic Blood Pressure Lowering on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2006-11","conditions":"Hypertension, Diastolic Dysfunction","enrollment":229},{"nctId":"NCT01518855","phase":"PHASE4","title":"Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension","status":"COMPLETED","sponsor":"Bayer","startDate":"2004-03","conditions":"Hypertension","enrollment":514},{"nctId":"NCT00171561","phase":"PHASE4","title":"Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.","status":"COMPLETED","sponsor":"Novartis","startDate":"2003-03","conditions":"Hypertension","enrollment":144},{"nctId":"NCT00409643","phase":"PHASE3","title":"Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-01","conditions":"Hypertension","enrollment":1259},{"nctId":"NCT00327587","phase":"PHASE3","title":"8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-05","conditions":"Hypertension","enrollment":2279}],"_emaApprovals":[],"_faersSignals":[{"count":19,"reaction":"HYPERTENSION"},{"count":15,"reaction":"BLOOD PRESSURE INCREASED"},{"count":11,"reaction":"DRUG INEFFECTIVE"},{"count":8,"reaction":"FATIGUE"},{"count":8,"reaction":"MALAISE"},{"count":6,"reaction":"HYPOTENSION"},{"count":5,"reaction":"DRUG INTERACTION"},{"count":5,"reaction":"DYSPNOEA"},{"count":5,"reaction":"HEADACHE"},{"count":5,"reaction":"OEDEMA PERIPHERAL"}],"_approvalHistory":[],"publicationCount":98,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Exforge®"],"phase":"marketed","status":"active","brandName":"valsartan/amlodipine","genericName":"valsartan/amlodipine","companyName":"Novartis","companyId":"novartis","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Valsartan blocks angiotensin II receptors to lower blood pressure, while amlodipine blocks calcium channels to relax blood vessels and reduce cardiac workload. Used for Hypertension, Hypertension in patients not adequately controlled on monotherapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}