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

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-05-27
Last Posted Date
2010-06-14
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
24
Registration Number
NCT01131936
Locations
🇺🇸

AAI Clinic, Chapel Hill, North Carolina, United States

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-05-20
Last Posted Date
2010-09-14
Lead Sponsor
Hanmi Pharmaceutical Company Limited
Target Recruit Count
149
Registration Number
NCT01127217
Locations
🇰🇷

8 Sites, Seoul, Korea, Republic of

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

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-05-18
Last Posted Date
2015-01-05
Lead Sponsor
University of Campinas, Brazil
Target Recruit Count
10
Registration Number
NCT01125254
Locations
🇧🇷

University of Campinas, Campinas, SP, Brazil

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

First Posted Date
2010-05-10
Last Posted Date
2010-05-10
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
212
Registration Number
NCT01120327
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

First Posted Date
2010-04-15
Last Posted Date
2014-06-27
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
324
Registration Number
NCT01103960
Locations
🇨🇳

1235.29.86002 Boehringer Ingelheim Investigational Site, Shanghai, China

🇵🇭

1235.29.63018 Boehringer Ingelheim Investigational Site, Metro Manila, Philippines

🇨🇳

1235.29.86001 Boehringer Ingelheim Investigational Site, Beijing, China

and more 13 locations

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

First Posted Date
2010-03-04
Last Posted Date
2011-12-26
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
31
Registration Number
NCT01080768
Locations
🇳🇱

Novartis Investigative Site, Wildervank, Netherlands

Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-10-30
Last Posted Date
2021-01-28
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
48
Registration Number
NCT01004614
Locations
🇯🇵

Pfizer Investigational Site, Minato-ku, Tokyo, Japan

Irbesartan Versus Amlodipine: The OBI Study

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2009-10-01
Last Posted Date
2014-02-11
Lead Sponsor
Aristotle University Of Thessaloniki
Registration Number
NCT00987662
Locations
🇬🇷

Hypertension-24h ABPM Center Papageorgiou Hospital, Thessaloniki, Greece

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-08-11
Last Posted Date
2010-10-26
Lead Sponsor
Sanofi
Target Recruit Count
406
Registration Number
NCT00956644
Locations
🇨🇴

Sanofi-Aventis Investigational Site Number 17004, Barranquilla, Colombia

🇨🇱

Sanofi-Aventis Investigational Site Number 15203, Santiago, Chile

🇧🇷

Sanofi-Aventis Investigational Site Number 076-002, São Paulo, Brazil

and more 37 locations

Irbesartan and Amlodipine Combination in Controlling Blood Pressure

First Posted Date
2009-07-31
Last Posted Date
2011-01-05
Lead Sponsor
Sanofi
Target Recruit Count
270
Registration Number
NCT00950066
Locations
🇨🇳

Sanofi-Aventis Administrative Office, Taipei, Taiwan

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