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
C20H25ClN2O5
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
-

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

Phase 2
Completed
Conditions
First Posted Date
2009-07-20
Last Posted Date
2009-07-20
Lead Sponsor
Hanmi Pharmaceutical Company Limited
Target Recruit Count
320
Registration Number
NCT00942344
Locations
🇰🇷

14 sites in Korea, Seoul, Busan, etc., Korea, Republic of

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-07-16
Last Posted Date
2016-10-12
Lead Sponsor
Hanmi Pharmaceutical Company Limited
Target Recruit Count
185
Registration Number
NCT00940667
Locations
🇰🇷

13 sites in Korea, Seoul, Busan, etc., Korea, Republic of

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

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-07-13
Last Posted Date
2009-10-08
Lead Sponsor
Boryung Pharmaceutical Co., Ltd
Target Recruit Count
34
Registration Number
NCT00938197
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

First Posted Date
2009-07-09
Last Posted Date
2011-10-26
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
124
Registration Number
NCT00935805
Locations
🇧🇷

Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 22 Fasted, Healthy Adult Subjects

Phase 1
Completed
Conditions
First Posted Date
2009-07-03
Last Posted Date
2009-07-17
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT00932763
Locations
🇺🇸

CEDRA Clinical Research, LLC, San Antonio, Texas, United States

Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 18 Fed, Healthy Adult Subjects

Phase 1
Completed
Conditions
First Posted Date
2009-07-03
Last Posted Date
2009-07-16
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT00932880
Locations
🇺🇸

CEDRA Clinical Research, LLC, San Antonio, Texas, United States

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

First Posted Date
2009-06-16
Last Posted Date
2009-06-17
Lead Sponsor
Gulhane School of Medicine
Target Recruit Count
105
Registration Number
NCT00921570
Locations
🇹🇷

GATA Nephrology, Ankara, Turkey

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

First Posted Date
2009-03-12
Last Posted Date
2014-05-20
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
858
Registration Number
NCT00860262
Locations
🇧🇬

1235.20.008 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

🇭🇺

1235.20.152 Boehringer Ingelheim Investigational Site, Budapest, Hungary

🇷🇴

1235.20.254 Boehringer Ingelheim Investigational Site, Iasi, Romania

and more 134 locations

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

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-03-02
Last Posted Date
2012-04-30
Lead Sponsor
Novartis
Target Recruit Count
443
Registration Number
NCT00853957
Locations
🇺🇸

Investigative Site, Milwaukeee, Wisconsin, United States

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