Norvasc

(Amlodipine)

ApprovedSmall molecule

Amlodipine is used to treat high blood pressure and chest pain (angina) by relaxing blood vessels and improving blood flow.[2] Norvasc is currently approved and in use across 37 indications[4].[1]

Norvasc is one of 742 small molecule programs targeting Blood Pressure. It is currently in Approved.

Indications

236

Total Trials

Active Trials

741

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Blood PressureCompleted

Type 2 Diabetes MellitusApproved

Hypertrophic CardiomyopathyApproved

Abdominal Aortic AneurysmApproved

Liver DiseaseApproved

Aortic Valve InsufficiencyApproved

HyperlipidemiaApproved

Coronary Artery DiseaseApproved

Essential Hypertension, GeneticApproved

Morbid ObesityApproved

Blood PressureApproved

Completed

Type 2 Diabetes MellitusApproved

Approved

Hypertrophic CardiomyopathyApproved

Approved

Abdominal Aortic AneurysmApproved

Approved

Liver DiseaseApproved

Approved

Aortic Valve InsufficiencyApproved

Approved

HyperlipidemiaApproved

Approved

Coronary Artery DiseaseApproved

Approved

Essential Hypertension, GeneticApproved

Approved

Morbid ObesityApproved

Approved

Showing 10 of 37 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Norvasc

VViatris Specialty LLC

Approved

3 2

Cagrilintide

Novo Nordisk

Phase 3

9 3

Revlimid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

1 4

Synthroid

IInstitut Jerome Lejeune

Phase 3

1 5

Vivia

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Phase 3

1 6

Enavogliflozin

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 7

Cagrisema

Novo Nordisk

Phase 3

5 8

Gemtesa

Sumitomo Pharma America, Inc.

Phase 3

1 9

Eloralintide

Mibavademab

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Hypertension

NCT05416840

Phase 2/3Recruiting

Efficacy

NCT06424834

Q2 2027

Post-ApprovalNot yet recruiting

Overweight

NCT07241338

Q4 2027

Phase 2Not yet recruiting

Endometrial Cancer

NCT06942377

Q4 2030

Phase 1Not yet recruiting

Myotonic Dystrophy Type 1

NCT07075965

Phase 1/2Recruiting

Obesity

NCT05312892

Clinical

Trials by Indication[1]

Hypertension54 trials

Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension

Terminated· Novartis logo

Novartis·Phase 2·NCT01080768·31 enrolled

Mechanism of Masked Hypertension - Intervention

Withdrawn·UUniversity of Alabama at Birmingham·Phase 3·NCT04121299

Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00174330·330 enrolled

Show 51 more trials

Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00553267·947 enrolled

Amlodipine Diabetic Hypertension Efficacy Response Trial

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00159692·739 enrolled

The Effects of Renin Angiotensin System Blockage (RAS), Calcium Channel Blocker and Combined Drugs on TWEAK, PTX3 and FMD Levels in Diabetic Proteinuric Patients With Hypertension

Completed·GGulhane School of Medicine·Phase 4·NCT00921570·105 enrolled

Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 4·NCT03666351·128 enrolled

Genetics of Hypertension Associated Treatments (GenHAT)

Completed·DDonna Arnett, 257-5678··NCT00006294·37,939 enrolled

Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00558428·1,098 enrolled

Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00765674·1,191 enrolled

Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal

Completed·JJohns Hopkins Bloomberg School of Public Health·N/A·NCT04521582·1,428 enrolled

Efficacy of Valsartan/Hydrochlorothiazide Versus Amlodipine and Hydrochlorothiazide in Patients Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00425997·480 enrolled

Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension

Terminated·AAmsterdam UMC, location VUmc·N/A·NCT01425242·3 enrolled

Olmesartan as an add-on to Amlodipine in Hypertension

Completed·SSankyo Pharma Gmbh·Phase 3·NCT00220233·632 enrolled

A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 3·NCT04074551·145 enrolled

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

Terminated· Novartis logo

Novartis·Phase 4·NCT01368536·975 enrolled

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

Completed· Novartis logo

Novartis·Phase 4·NCT00304226·1,288 enrolled

Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)

Completed· Alnylam Pharmaceuticals logo

Alnylam Pharmaceuticals·Phase 2·NCT05103332·663 enrolled

N-of-1 Trials In Children With Hypertension

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03461003·49 enrolled

Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00797862·1,254 enrolled

Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00860262·858 enrolled

Non-invasive Haemodynamic Assessment in Hypertension

Completed·MMilitary Institute od Medicine National Research Institute·N/A·NCT01996085·144 enrolled

Clinical Efficacy of Telmisartan in Reducing Cardiac Remodeling Among Obese Patients With Hypertension

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·N/A·NCT03956823·300 enrolled

A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT01658657·17 enrolled

Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00171054·125 enrolled

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00523744·257 enrolled

Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension

Completed·QQueen Mary University of London·Phase 4·NCT04559074·343 enrolled

Black Education and Treatment of Hypertension (BEAT HTN)

Completed·—·Phase 4·NCT00661895·99 enrolled

Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension

Completed· Novartis logo

Novartis·Phase 2·NCT01692301·454 enrolled

Amlodipine as add-on to Olmesartan in Hypertension

Completed·SSankyo Pharma Gmbh·Phase 3·NCT00220220·429 enrolled

Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00853957·443 enrolled

Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension

Not yet recruiting·JJing Liu·Phase 4·NCT05416840·92 enrolled

RAS Peptide Profiles in Patients With Arterial Hypertension

Completed·IInsel Gruppe AG, University Hospital Bern··NCT02449811·107 enrolled

Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT01316419·2,089 enrolled

Personalised Electronic Record Supported Optimisation of Amlodipine for Patients With Hypertension

Withdrawn·QQueen Mary University of London·Phase 4·NCT06713785

Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

Completed·AAnthony J Viera, MD, MPH·N/A·NCT02121041·28 enrolled

Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient

Completed· Pfizer logo

Pfizer·Phase 3·NCT00443456·134 enrolled

Amlodipine Versus Valsartan for Improvement of Diastolic Dysfunction Associated With Hypertension

Completed·—·Phase 4·NCT02973035·104 enrolled

Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00649389·2,500 enrolled

Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension

Withdrawn· Novartis logo

Novartis·Phase 3·NCT01865188

Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00765947·256 enrolled

Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 3·NCT01127217·149 enrolled

Anti Inflammatory Treatment of Hypertension

Completed·—·Phase 2/3·NCT04740840·200 enrolled

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

Completed· Novartis logo

Novartis·Phase 4·NCT00351130·79 enrolled

Treatment of Mild Hypertension Study (TOMHS)

Completed·UUniversity of Minnesota·Phase 2·NCT00000522

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

Completed· Novartis logo

Novartis·Phase 3·NCT00841672·485 enrolled

Manidipine Versus Amlodipine in Patients With Hypertension

Terminated·KKorea University Guro Hospital·Phase 4·NCT03106597·46 enrolled

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00281580·1,461 enrolled

Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00413049·698 enrolled

A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

Completed· Novartis logo

Novartis·Phase 2·NCT01870739·115 enrolled

Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

Unknown status·RRoyal Perth Hospital·Phase 4·NCT04474899·120 enrolled

Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone

Completed· Novartis logo

Novartis·Phase 3·NCT00778921·847 enrolled

Treatment of Early Hypertension Among Persons Living With HIV in Haiti

Completed·WWeill Medical College of Cornell University·Phase 2·NCT04692467·250 enrolled

Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05165251·480 enrolled

Essential Hypertension18 trials

A Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension

Completed·HHelsinki University Central Hospital·Phase 4·NCT03276598·233 enrolled

A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 2·NCT03897868·248 enrolled

Intensive Vasodilator Therapy in Patients With Essential Hypertension

Completed·—·Phase 4·NCT01180413·48 enrolled

Show 15 more trials

Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension

Completed·TThe University of Texas Health Science Center, Houston·N/A·NCT02412761·42 enrolled

Essential Hypertension

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 2·NCT01264692·196 enrolled

Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 3·NCT00940667·185 enrolled

Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension

Completed· Takeda logo

Takeda·Phase 3·NCT00591266·566 enrolled

An Efficacy and Safety Study Evaluating the Fixed-Dose Combination of Candesartan Plus Amlodipine in Participants With Mild/Moderate Essential Hypertension

Withdrawn· Takeda logo

Takeda·Phase 3·NCT02969265

A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00667719·564 enrolled

Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg

Completed· Novartis logo

Novartis·Phase 4·NCT00687973·393 enrolled

Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT01237223·1,342 enrolled

Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension

Completed·SShin Poong Pharmaceutical Co. Ltd.·Phase 2·NCT02944734·392 enrolled

Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00437645·1,183 enrolled

A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension

Unknown status· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 2·NCT02206165·456 enrolled

Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00739973·2,694 enrolled

Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00699192·965 enrolled

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 2/3·NCT00425373·1,474 enrolled

Comparing Safety and Efficacy of Amlodipine Verses S Amlodipine in Patients With Essential Hypertension

Unknown status· Ahn-Gook Pharmaceuticals Co.,Ltd logo

Ahn-Gook Pharmaceuticals Co.,Ltd··NCT04554303·80 enrolled

Interaction9 trials

A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

Completed· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 1·NCT00938197·34 enrolled

The Pharmacokinetic Interaction Between Amlodipine and Losartan

Completed·KKorea University Anam Hospital·Phase 1·NCT03912285·24 enrolled

Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

Completed· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 1·NCT02397538·50 enrolled

Show 6 more trials

A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers

Completed·SSt Stephens Aids Trust·Phase 1·NCT01841593·19 enrolled

A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers

Withdrawn·OOttawa Hospital Research Institute·Phase 1·NCT01549496

Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)

Completed·YYuhan Corporation·Phase 1·NCT02152969·66 enrolled

The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Completed·YYuhan Corporation·Phase 1·NCT02233218·60 enrolled

A Study to Evaluate the Drug-drug Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide

Completed· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 1·NCT03889145·30 enrolled

CKD-330 Drug-Drug Interaction Study (Amlodipine)

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 1·NCT02064556·24 enrolled

Blood Pressure9 trials

Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

Recruiting·RRadboud University Medical Center·Phase 4·NCT05917275·96 enrolled

Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine

Unknown status·SShenzhen Ausa Pharmed Co.,Ltd·Phase 2/3·NCT01956786·540 enrolled

Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day

Completed· Novartis logo

Novartis·Phase 4·NCT00700271·478 enrolled

Show 6 more trials

Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan

Withdrawn·HHospital Universitario Pedro Ernesto·Phase 4·NCT01409408

Skin Sodium and Salt Sensitivity of Blood Pressure

Unknown status·—·N/A·NCT05976438·60 enrolled

Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine

Unknown status·SShenzhen Ausa Pharmed Co.,Ltd·Phase 2/3·NCT01848873·756 enrolled

A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives

Terminated·UUniversity of Mississippi Medical Center·N/A·NCT00825188·10 enrolled

N-of-1 Trials for Blood Pressure Medications in Adults

Completed·—·Phase 1·NCT02744456·10 enrolled

Amlodipine Prevents Morning Blood Pressure Surge Study

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01030081·510 enrolled

Hypertensive7 trials

Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects

Completed· Novartis logo

Novartis·Phase 2·NCT01631864·98 enrolled

Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy

Completed· Sanofi logo

Sanofi·Phase 3·NCT00956644·406 enrolled

A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

Completed· Novartis logo

Novartis·Phase 3·NCT00327145·894 enrolled

Show 4 more trials

Effects Of Losartan On Myocardial Structure In Diabetic Hypertensive Patients With Left Ventricular

Unknown status·UUniversity of Pavia·Phase 3·NCT00659451·100 enrolled

Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01337674·26 enrolled

Phase 4 Study of the Efficacy of Losartan Based Therapy in Hypertensives With and Without Diabetes

Withdrawn·TThe University of The West Indies·Phase 4·NCT03978884

A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT00627952·100 enrolled

62 more indications

Tics6 trials

To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets

Completed· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 1·NCT02205151·86 enrolled

Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers

Completed·HHandok Inc.·Phase 1·NCT05663073·46 enrolled

Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers

Completed·HHandok Inc.·Phase 1·NCT05688085·44 enrolled

Show 3 more trials

Pharmacokinetics of Telmisartan Alone and in Combination With Amlodipine in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02259816·38 enrolled

Study to Compare the Safety and Pharmacokinetics of CKD-330 8/5mg With Coadministration of the Two Separate Drugs

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 1·NCT02548286·53 enrolled

Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

Completed·HHanAll BioPharma Co., Ltd.·Phase 1·NCT01806311·36 enrolled

ART5 trials

Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02259790·30 enrolled

Irbesartan Versus Amlodipine: The OBI Study

Withdrawn·—·Phase 4·NCT00987662

Relative Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02259803·30 enrolled

Show 2 more trials

Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02129192·72 enrolled

Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01286558·225 enrolled

Trial4 trials

INTERVENCION Trial

Completed·PPrevencion·Phase 4·NCT02373163·166 enrolled

Filtered Trial for Amlodipine Non-responder

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00558064·531 enrolled

Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03226275·32 enrolled

Show 1 more trial

CKD-330 Phase 3 Trial in Amlodipine Non-responder

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 3·NCT02586311·160 enrolled

AML4 trials

Bedtime Administration of Amlodipine Versus Lisinopril

Unknown status·—·N/A·NCT01835418·100 enrolled

Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions

Completed·—·Phase 1·NCT01131936·24 enrolled

Bioequivalency Study of Amlodipine Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00601302·40 enrolled

Show 1 more trial

Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects

Completed·TThe Affiliated Hospital of Qingdao University·Phase 1·NCT04411875·48 enrolled

Efficacy and Safety4 trials

Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01911780·132 enrolled

A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

Unknown status·SSeoul National University Hospital·Phase 4·NCT01120327·212 enrolled

Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine

Completed· Novartis logo

Novartis·Phase 3·NCT01663233·266 enrolled

Show 1 more trial

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

Completed· Novartis logo

Novartis·Phase 3·NCT00360178·198 enrolled

Safety and Efficacy4 trials

A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly

Completed· Novartis logo

Novartis·Phase 3·NCT00368277·901 enrolled

Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00409643·1,259 enrolled

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00654745·207 enrolled

Show 1 more trial

Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients

Completed· Novartis logo

Novartis·Phase 4·NCT00426478·80 enrolled

High Blood Pressure3 trials

A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00791258·999 enrolled

Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00185120·152 enrolled

An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

Completed· Novartis logo

Novartis·Phase 3·NCT00402103·556 enrolled

Thalassemia3 trials

Amlodipine for Myocardial Iron in Thalassemia

Completed·—·Phase 2/3·NCT02065492·20 enrolled

Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Thalassemia Patients

Unknown status·KKevin H.M. Kuo, MD, MSc, FRCPC·N/A·NCT02474420·60 enrolled

Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major

Completed·UUniversity of Campinas, Brazil·Phase 3·NCT01395199·62 enrolled

Fasting Conditions3 trials

Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00602017·40 enrolled

Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fasting Conditions

Completed·—·Phase 1·NCT01131923·26 enrolled

Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00775905·40 enrolled

Metabolic Syndrome3 trials

Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome

Terminated· Novartis logo

Novartis·Phase 4·NCT00542269·178 enrolled

Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00891267·60 enrolled

Gut Microbiomes in Patients With Metabolic Syndrome

Unknown status·—··NCT03489317·1,000 enrolled

Biomarkers2 trials

Direct Renin Inhibition Effects on Atherosclerotic Biomarkers

Completed·TTexas Tech University Health Sciences Center·Phase 4·NCT00818779·38 enrolled

ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

Completed· Novartis logo

Novartis·Phase 4·NCT01176032·74 enrolled

Obesity2 trials

Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes

Completed·TThird Military Medical University·Phase 4·NCT00847262·120 enrolled

Sympathetic Mechanisms in Obesity-Crossover Design

Recruiting·VVanderbilt University Medical Center·Phase 1/2·NCT05312892·12 enrolled

Type 2 Diabetes2 trials

Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes-----renal Substudy

Withdrawn·GGuangdong Provincial People's Hospital·Phase 4·NCT04978649

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT00535925·850 enrolled

Ischemic stroke2 trials

The Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke (0954-338)(COMPLETED)

Completed·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT00754429·40 enrolled

Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis

Unknown status·RRenJi Hospital·N/A·NCT01665235·200 enrolled

Oral2 trials

Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01004614·48 enrolled

Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02194309·24 enrolled

Sleep Apnea2 trials

Effect of Antihypertensive Agents on Diastolic Function in Patients With Sleep Apnea

Completed·HHospital de Clinicas de Porto Alegre·Phase 3·NCT02896621·69 enrolled

Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome

Unknown status·FFirst Affiliated Hospital of Harbin Medical University·Phase 2/3·NCT02408172·20 enrolled

Effectiveness2 trials

Effectiveness and Safety of Combination of Amlodipine and Zofenopril in Hypertensive Patients Versus Each Monotherapy

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT05279807·277 enrolled

Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT05513937·301 enrolled

Female2 trials

Bioequivalence of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02193308·84 enrolled

Bioequivalence Study of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02259829·84 enrolled

Left Ventricular Hypertrophy2 trials

Sacubitril/Valsartan Versus Amlodipine in Hypertension and Left Ventricular Hypertrophy.

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT04929600·120 enrolled

Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

Completed· Novartis logo

Novartis·Phase 3·NCT00446563·90 enrolled

Efficacy2 trials

Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

Recruiting·SStanford University·Phase 2/3·NCT06424834·150 enrolled

A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00819104·402 enrolled

Atorvastatin2 trials

Double Blind Atorvastatin Amlodipine Study

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00159718·360 enrolled

Amlodipine Plus/Minus Atorvastatin for Protection of Arteries

Unknown status·SShanghai Institute of Hypertension·Phase 4·NCT01922687·109 enrolled

Platelet Reactivity1 trial

Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT01490255·100 enrolled

Glucose intolerance1 trial

Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

Completed·NNagoya University·Phase 4·NCT00129233·1,150 enrolled

Endothelial Dysfunction1 trial

Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome

Completed· Novartis logo

Novartis·Phase 2·NCT00417170·48 enrolled

Metabolism1 trial

Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism

Completed·VVanderbilt University Medical Center·Phase 4·NCT02034435·44 enrolled

Diabetes Mellitus1 trial

Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

Completed· Novartis logo

Novartis·Phase 4·NCT00787605·860 enrolled

Insulin Sensitivity1 trial

Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance

Terminated·—·N/A·NCT01252238·24 enrolled

Double-blind1 trial

A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients

Completed·TThird Military Medical University·Phase 4·NCT00538486·360 enrolled

Drug1 trial

Amlodipine 10mg Drug Use Investigation

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT01252563·14,141 enrolled

Heart Failure1 trial

Effects of Amlodipine in the Management of Chronic Heart Failure

Terminated·RRennes University Hospital·Phase 2·NCT00151619·7 enrolled

Kidney Disease1 trial

African American Study of Kidney Disease and Hypertension

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT04364139·1,094 enrolled

Randomized Controlled Trial1 trial

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People

Terminated· Novartis logo

Novartis·Phase 3·NCT01259297·2,336 enrolled

Ovarian1 trial

Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

Completed·AAhmed Fathy Ali Mohamed Ghanem·N/A·NCT02544776·60 enrolled

CAR1 trial

Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00242814·100 enrolled

Myotonic Dystrophy Type 11 trial

Calcium Channel Blocker in Myotonic Dystrophy Type 1

Not yet recruiting·UUniversity of Rochester·Phase 1·NCT07075965·20 enrolled

Ischemia1 trial

Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia

Completed·LLuzerner Kantonsspital·N/A·NCT00382421

Bariatric Surgery1 trial

Bariatric Surgery and Pharmacokinetics of Amlodipine

Recruiting·NNorwegian University of Science and Technology··NCT02904291·12 enrolled

Kidney Transplant1 trial

Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus

Completed·EErasmus Medical Center·Phase 3·NCT02644395·49 enrolled

Lower Urinary Tract Symptom1 trial

Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension

Completed·—·N/A·NCT00693199·360 enrolled

Chronic Stable Angina1 trial

Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00143195·200 enrolled

Hypoxia1 trial

Intermittent Hypoxia 2: Cardiovascular and Metabolism

Terminated·UUniversity Hospital, Grenoble·Phase 4·NCT02058823·12 enrolled

Vascular Inflammation1 trial

Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue

Unknown status·KKurume University·Phase 4·NCT02996916·100 enrolled

Spironolactone1 trial

Spironolactone Versus Indapamide in Obese and Hypertensive Patients

Unknown status·PPeking University Third Hospital·N/A·NCT03626506·400 enrolled

Breast Cancer1 trial

L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients

Completed·TThe Methodist Hospital Research Institute·Phase 1/2·NCT02834403·37 enrolled

Newly Diagnosed1 trial

Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients

Completed·—·Phase 4·NCT05467384·80 enrolled

Combination Therapy1 trial

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

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 3·NCT02651870·135 enrolled

Endometrial Cancer1 trial

Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT06942377·140 enrolled

Beta-Thalassemia1 trial

Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia

Completed·TTanta University·N/A·NCT02671695·40 enrolled

Depression1 trial

Vascular Augmentation of Late-life Unremitted Depression (VALUeD)

Unknown status·GGateshead Health NHS Foundation Trust·Phase 3·NCT01557153·80 enrolled

LSD1 trial

MR Antagonist and LSD1

Active, not recruiting·—·Phase 4·NCT04840342·300 enrolled

Heart Attack1 trial

Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000542

Coronary Artery Disease1 trial

Effect of Amlodipine on Anti-platelet Drug Effect in Patients With Coronary Artery Disease

Completed·RRuttonjee Hospital·Phase 4·NCT01203696·97 enrolled

Blood Pressure Variability1 trial

Comparision of Blood Pressure Variability Between Amlodipine and Losartan

Completed·WWonju Severance Christian Hospital·Phase 4·NCT01964079·144 enrolled

Insulin Secretion1 trial

Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients

Completed·SSeoul National University Hospital·N/A·NCT02312375·46 enrolled

Microvascular Function1 trial

Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function

Terminated·LLudwig-Maximilians - University of Munich·Phase 3·NCT03082014·101 enrolled

Type 1 Diabetes1 trial

The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes

Completed·UUniversity of Aarhus·N/A·NCT00337298·25 enrolled

Overweight1 trial

Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity

Not yet recruiting·JJing Liu·Phase 4·NCT07241338·104 enrolled

Proteinuria1 trial

Effect of Calcium Channel Blocker on the Serum Fibrobalst Growth Factor-23 (FGF-23) Levels in Type-2 Diabetic Patients With Proteinuria Purpose

Completed·GGulhane School of Medicine·Phase 4·NCT01738945·32 enrolled

Elderly Patients1 trial

Effect of RAS Blockers on CKD Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)

Unknown status·HHospital General Universitario Gregorio Marañon·Phase 4·NCT03195023·106 enrolled

Alcoholic Fatty Liver Disease1 trial

Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT02213224·180 enrolled

Frozen Embryo Transfer1 trial

Benefit of Amlodipine in HRT Cycle for Frozen Embryo Transfer in the Correction of Uterine Pulsatility Index

Withdrawn·UUniversity Hospital, Montpellier·Phase 2·NCT04954196

Unspecified2 trials

DP-R212 Pharmacokinetic Study

Unknown status·AAlvogen Korea·Phase 1·NCT02789475·38 enrolled

DP-R212 Pharmacokinetic Study Phase I

Unknown status·AAlvogen Korea·Phase 1·NCT02814500·36 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 31, 1992

NORVASC

NDA NDA019787

Oct 31, 2003

AMVAZ

NDA NDA021435

Sep 27, 2007

AMLODIPINE BESYLATE

NDA NDA022026

Jul 8, 2019

KATERZIA

NDA NDA211340

Feb 24, 2022

NORLIQVA

NDA NDA214439

Jul 24, 2025

SDAMLO

NDA NDA219531

Sources

References

[1]
ClinicalTrials.gov — 236 trial records for Amlodipine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Norvasc drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Amlodipine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Amlodipine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219531). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Norvasc. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Viatris Specialty LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Voltage-Gated L-Type Calcium Channel Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VViatris Specialty LLC

Patent Landscape[6]

Patent Cliff

Oct 6, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12721843Oct 6, 2037

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