Carvedilol

Generic Name: Carvedilol

Brand Names: Coreg

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₆N_₂O_₄

CAS Number: 72956-09-3

Unique Ingredient Identifier: 0K47UL67F2

Background: Carvedilol is a racemic mixture where the S(-) enantiomer is both a beta and alpha-1 adrenoceptor blocker, and the R(+) enantiomer is an alpha-1 adrenoceptor blocker. It is currently used to treat heart failure, left ventricular dysfunction, and hypertension. The dual action of carvedilol is advantageous in combination therapies as moderate doses of 2 drugs have a decreased incidence of adverse effects compared to high dose monotherapy in the treatment of moderate hypertension.

Carvedilol was granted FDA approval on 14 September 1995.

Indication: Carvedilol is indicated to treat mild to severe heart failure, left ventricular dysfunction after myocardial infarction with ventricular ejection fraction ≤40%, or hypertension.

Associated Conditions: Atrial Fibrillation, Chronic Stable Angina Pectoris, Hypertension, LVEF ≤40% Left ventricular dysfunction, NYHA Class I or II heart failure, Chronic heart failure with reduced ejection fraction (NYHA Class III), Chronic heart failure with reduced ejection fraction (NYHA Class IV)

Associated Therapies: -

Clinical Trials

Bioequivalence Study of Carvedilol Tablets USP 12.5 mg Under Fasting Condition

Phase 1

Completed

Conditions: Fasting State

Interventions: Drug: Carvedilol Tablets USP 12.5 mg
Drug: Carvedilol

First Posted Date: 2012-04-16

Last Posted Date: 2012-07-09

Lead Sponsor: IPCA Laboratories Ltd.

Target Recruit Count: 42

Registration Number: NCT01577914

Locations: 🇮🇳
Accutest Research Lab (I) Pvt. Ltd., Ahmedabad, Gujarat, India

Imatinib and Carvedilol for High Blood Pressure in the Lungs in Adults With Sickle Cell Disease

Phase 1

Withdrawn

Conditions: Pulmonary Hypertension

First Posted Date: 2012-04-02

Last Posted Date: 2018-07-05

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Registration Number: NCT01568645

Carvedilol Vascular Efficacy Trial

Completed

Conditions: Acute Myocardial Infarction
Heart Failure

Interventions: Drug: Carvedilol

First Posted Date: 2011-12-02

Last Posted Date: 2023-11-01

Lead Sponsor: Elpen Pharmaceutical Co. Inc.

Target Recruit Count: 415

Registration Number: NCT01484327

Locations: 🇬🇷
Cardiology University Clinic, Alexandroupolis, Greece

Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

Phase 4

Conditions: Coronary Heart Disease
Angina
Hemodialysis

Interventions: Drug: Ivabradine
Drug: Carvedilol

First Posted Date: 2011-08-29

Last Posted Date: 2012-06-28

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Target Recruit Count: 220

Registration Number: NCT01425164

Locations: 🇮🇹
Chair of Cardiology Second University of Naples, Naples, Italy

Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding

Phase 4

Terminated

Conditions: Variceal Bleeding

Interventions: Procedure: EVL + carvedilol
Drug: carvedilol

First Posted Date: 2011-06-28

Last Posted Date: 2020-11-20

Lead Sponsor: E-DA Hospital

Target Recruit Count: 65

Registration Number: NCT01383044

Locations: 🇨🇳
E-DA hospital, Kaogsiung, Taiwan

Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

Phase 1

Completed

Conditions: Chronic Stable Angina

Interventions: Drug: Dilatrend SR capsule

First Posted Date: 2011-06-09

Last Posted Date: 2012-02-15

Lead Sponsor: Chong Kun Dang Pharmaceutical

Target Recruit Count: 30

Registration Number: NCT01369472

Locations: 🇰🇷
Asan Medcial Center, Songpa-gu, Seoul, Korea, Republic of

Trial of Carvedilol in Alzheimer's Disease

Phase 4

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: Placebo
Drug: Carvedilol

First Posted Date: 2011-05-16

Last Posted Date: 2018-02-06

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 29

Registration Number: NCT01354444

Locations: 🇺🇸
Johns Hopkins School of Medicine Bayview Campus, Baltimore, Maryland, United States

A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers

Phase 1

Completed

Conditions: Chronic Stable Angina

Interventions: Drug: Dilatrend 64mg capsule

First Posted Date: 2011-04-22

Last Posted Date: 2011-12-22

Lead Sponsor: Chong Kun Dang Pharmaceutical

Target Recruit Count: 24

Registration Number: NCT01340248

Locations: 🇰🇷
Kyungpook national university, Daegu, Seoul, Korea, Republic of

Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)

Not Applicable

Completed

Conditions: Mood Disorder
Substance-Related Disorders
Amphetamine-Related Disorders

Interventions: Drug: 3,4-Methylenedioxymethamphetamine
Drug: carvedilol
Drug: placebo

First Posted Date: 2011-01-05

Last Posted Date: 2018-12-11

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 16

Registration Number: NCT01270672

Locations: 🇨🇭
Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland

Mechanisms of Improvement With Beta-Blocker Treatment in Heart Failure

Phase 4

Completed

Conditions: Heart Failure
Cardiomyopathy

First Posted Date: 2010-12-16

Last Posted Date: 2010-12-16

Lead Sponsor: Michael E. DeBakey VA Medical Center

Target Recruit Count: 55

Registration Number: NCT01261065

Locations: 🇺🇸
Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, United States

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