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

Clinical Trials

Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension

Phase 3

Recruiting

Conditions: Hypertension

Interventions: Drug: candesartan cilexetil + chlorthalidone + amlodipine
Drug: Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)

First Posted Date: 2023-06-27

Last Posted Date: 2023-08-24

Lead Sponsor: Hospital Israelita Albert Einstein

Target Recruit Count: 698

Registration Number: NCT05920005

Locations: 🇧🇷
Vitoria Clinical Research Institute LTDA, Vitória, Espírito Santo, Brazil
🇧🇷
Instituto Atena de Pesquisa Clinica LTDA, Natal, Rio Grande Do Norte, Brazil
🇧🇷
Centro de Pesquisas Clinicas Dr. Marco Mota (Centro Universitario Cesmac/ Hospital do Coração de Alagoas), Maceió, Alagoas, Brazil

and more 19 locations

Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

Phase 4

Recruiting

Conditions: Primary Hypertension

Interventions: Drug: Amlodipine
Drug: Olmesartan
Drug: Hydrochlorothiazide
Drug: Amlodipine/Olmesartan

First Posted Date: 2023-06-23

Last Posted Date: 2024-06-10

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 96

Registration Number: NCT05917275

Locations: 🇳🇱
Radboudumc, Nijmegen, Netherlands

Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

Phase 1

Completed

Conditions: Hypertension
Coronary Artery Disease

Interventions: Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
Drug: Norvasc 5 mg tablets of Pfizer Labs

First Posted Date: 2023-04-11

Last Posted Date: 2023-06-07

Lead Sponsor: Brillian Pharma Inc.

Target Recruit Count: 24

Registration Number: NCT05808725

Locations: 🇮🇳
Accutest Research Laboratories (I) Pvt. Ltd., Vadodara, Gujarat, India

Description of the Effectiveness, Safety, Tolerability and Adherence to Amlodipine/Atorvastatin/Perindopril Single Pill Combination Treatment in Patients With Arterial Hypertension and Dyslipidemia (TARGET)

Completed

Conditions: Arterial Hypertension
HTN

First Posted Date: 2023-03-10

Last Posted Date: 2024-04-19

Lead Sponsor: Servier Russia

Target Recruit Count: 409

Registration Number: NCT05764317

Locations: 🇷🇺
Servier, Moscow, Russian Federation

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

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Irbesartan High/Amlodipine FDC
Drug: Irbesartan High
Drug: Amlodipine

First Posted Date: 2023-01-18

Last Posted Date: 2023-08-18

Lead Sponsor: Handok Inc.

Target Recruit Count: 44

Registration Number: NCT05688085

Locations: 🇰🇷
H Plus Yangji Hospital, Seoul, Korea, Republic of

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

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Irbesartan/Amlodipine High FDC
Drug: Irbesartan
Drug: Amlodipine High

First Posted Date: 2023-01-18

Last Posted Date: 2023-08-18

Lead Sponsor: Handok Inc.

Target Recruit Count: 44

Registration Number: NCT05688098

Locations: 🇰🇷
H Plus Yangji Hospital, Seoul, Korea, Republic of

Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India

Phase 4

Completed

Conditions: Primary Hypertension

Interventions: Drug: Perindopril + Indapamide
Drug: Amlodipine + Indapamide
Drug: Amlodipine + Perindopril

First Posted Date: 2023-01-13

Last Posted Date: 2024-10-08

Lead Sponsor: Centre for Chronic Disease Control, India

Target Recruit Count: 1981

Registration Number: NCT05683301

Locations: 🇮🇳
Apollo Hospitals, Bhubaneshwar, Odisha, India
🇮🇳
Assam Medical College, Dibrugarh, Assam, India
🇮🇳
Indraprastha Apollo Hospitals, New Delhi, Delhi, India

and more 28 locations