Amlodipine

Generic Name: Amlodipine

Brand Names: Amlobenz, Azor, Caduet, Dafiro, Exforge, Exforge Hct, Katerzia, Lotrel, Norliqva, Norvasc, Prestalia, Tribenzor, Twynsta, Viacoram

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₅ClN_₂O_₅

CAS Number: 88150-42-9

Unique Ingredient Identifier: 1J444QC288

Background: Amlodipine, initially approved by the FDA in 1987, is a popular antihypertensive drug belonging to the group of drugs called dihydropyridine calcium channel blockers. Due to their selectivity for the peripheral blood vessels, dihydropyridine calcium channel blockers are associated with a lower incidence of myocardial depression and cardiac conduction abnormalities than other calcium channel blockers .

Amlodipine is commonly used in the treatment of high blood pressure and angina. Amlodipine has antioxidant properties and an ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure . The option for single daily dosing of amlodipine is an attractive feature of this drug .

Indication: Amlodipine may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of the following conditions :

• Hypertension

• Coronary artery disease

• Chronic stable angina

• Vasospastic angina (Prinzmetal’s or Variant angina)

• Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%

Associated Conditions: Cardiovascular Events, Chronic Stable Angina Pectoris, Coronary Artery Disease (CAD), Homozygous Familial Hypercholesterolaemia (HoFH), Hypertension, Hypertension, Essential Hypertension, Mixed Dyslipidemias, Primary Hypercholesterolemia, Vasospastic Angina

Associated Therapies: -

Clinical Trials

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

Phase 3

Terminated

Conditions: Cardiovascular Events

Interventions: Drug: Aliskiren
Drug: Hydrochlorothiazide (HCTZ)
Drug: Placebo for Amlodipine
Drug: Placebo for Hydrochlorothiazide (HCTZ)
Drug: Placebo for Aliskiren
Drug: Amlodipine

First Posted Date: 2010-12-14

Last Posted Date: 2014-04-08

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 2336

Registration Number: NCT01259297

Locations: 🇸🇪
Novartis Investigative Site, Stockholm, Sweden

A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Phase 2

Completed

Conditions: Essential Hypertension

Interventions: Drug: LCZ696
Drug: Amlodipine
Drug: Hydrochlorothiazide (HCTZ)

First Posted Date: 2010-12-08

Last Posted Date: 2015-10-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 341

Registration Number: NCT01256411

Locations: 🇹🇭
Novartis Investigative Site, Chiang Mai, Thailand

Amlodipine 10mg Drug Use Investigation

Completed

Conditions: Hypertension

Interventions: Drug: Amlodipine

First Posted Date: 2010-12-03

Last Posted Date: 2021-01-28

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 14141

Registration Number: NCT01252563

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

Not Applicable

Terminated

Conditions: Insulin Sensitivity
Aortic Compliance
Diastolic Function

Interventions: Drug: Valsartan and Aliskiren
Drug: Aliskiren
Drug: Amlodipine

First Posted Date: 2010-12-02

Last Posted Date: 2018-02-13

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 24

Registration Number: NCT01252238

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

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

Phase 4

Completed

Conditions: Ischemic Heart Disease

Interventions: Drug: Amlodipine

First Posted Date: 2010-09-16

Last Posted Date: 2012-06-06

Lead Sponsor: Ruttonjee Hospital

Target Recruit Count: 97

Registration Number: NCT01203696

Locations: 🇨🇳
Ruttonjee Hospital, Hong Kong SAR, China

Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

Phase 4

Completed

Conditions: Hypertension
Hypercholesterolemia
Angina Pectoris

Interventions: Drug: Caduet

First Posted Date: 2010-08-27

Last Posted Date: 2021-01-28

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 159

Registration Number: NCT01190007

Locations: 🇯🇵
Nakaoka Clinic, Osaka, Japan
🇯🇵
Healthcare Corporation MEDOC Medical Dock&Clinic, Nagoya, Aichi, Japan
🇯🇵
Oofuji Clinic, Amagasaki, Hyogo, Japan

and more 17 locations