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 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

Phase 3

Completed

Conditions: Hypertension

Interventions: Drug: manidipine 20 mg
Drug: amlodipine 10 mg
Drug: amlodipine 5 mg + delapril 30 mg
Drug: manidipine 10 mg + delapril 30 mg

First Posted Date: 2008-03-04

Last Posted Date: 2013-01-21

Lead Sponsor: University of Erlangen-Nürnberg Medical School

Target Recruit Count: 100

Registration Number: NCT00627952

Locations: 🇩🇪
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg, Erlangen, Bavaria, Germany

Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions

Not Applicable

Completed

Conditions: Hypertension
Chronic Stable Angina
Vasospastic Angina

First Posted Date: 2008-01-28

Last Posted Date: 2018-01-23

Lead Sponsor: Roxane Laboratories

Target Recruit Count: 40

Registration Number: NCT00602017

Locations: 🇺🇸
Gateway Medical Research, Inc., Saint Charles, Missouri, United States

Bioequivalency Study of Amlodipine Tablets Under Fed Conditions

Not Applicable

Completed

Conditions: Chronic Stable Angina
Vasospastic Angina
Hypertension

First Posted Date: 2008-01-28

Last Posted Date: 2018-01-23

Lead Sponsor: Roxane Laboratories

Target Recruit Count: 40

Registration Number: NCT00601302

Locations: 🇺🇸
Gateway Medical Research, Inc., Saint Charles, Missouri, United States

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

Phase 3

Completed

Conditions: Hypertension

Interventions: Drug: Amlodipine
Drug: Azilsartan Medoxomil and amlodipine

First Posted Date: 2008-01-11

Last Posted Date: 2011-07-22

Lead Sponsor: Takeda

Target Recruit Count: 566

Registration Number: NCT00591266

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

Phase 3

Completed

Conditions: Hypertension

First Posted Date: 2007-11-15

Last Posted Date: 2014-06-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1098

Registration Number: NCT00558428

Locations: 🇳🇱
1235.5.31004 Boehringer Ingelheim Investigational Site, Hoogwoud, Netherlands
🇳🇱
1235.5.31003 Boehringer Ingelheim Investigational Site, Musselkanaal, Netherlands
🇳🇱
1235.5.31005 Boehringer Ingelheim Investigational Site, Roelofarendsveen, Netherlands

and more 126 locations

Filtered Trial for Amlodipine Non-responder

Phase 3

Completed

Conditions: Hypertension

First Posted Date: 2007-11-14

Last Posted Date: 2014-07-08

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 531

Registration Number: NCT00558064

Locations: 🇯🇵
1235.13.009 Boehringer Ingelheim Investigational Site, Kiyose, Tokyo, Japan
🇯🇵
1235.13.002 Boehringer Ingelheim Investigational Site, Sendai, Miyagi, Japan
🇯🇵
1235.13.038 Boehringer Ingelheim Investigational Site, Kitaazumi-gun, Nagano, Japan

and more 38 locations

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

Phase 3

Completed

Conditions: Hypertension

First Posted Date: 2007-11-04

Last Posted Date: 2014-02-13

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 947

Registration Number: NCT00553267

Locations: 🇧🇬
1235.6.35904 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria
🇮🇪
1235.6.35304 Wilmer Road, Birr, Ireland
🇧🇬
1235.6.35902 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

and more 94 locations