MedPath

Carvedilol

Generic Name
Carvedilol
Brand Names
Coreg
Drug Type
Small Molecule
Chemical Formula
C24H26N2O4
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)

Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril

Phase 3
Completed
Conditions
Hypertension
Interventions
First Posted Date
2008-04-14
Last Posted Date
2022-05-27
Lead Sponsor
State University of New York at Buffalo
Target Recruit Count
30
Registration Number
NCT00657241
Locations
🇺🇸

Erie County Medical Center, Buffalo, New York, United States

Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
50
Registration Number
NCT00648622
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
50
Registration Number
NCT00650416
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Comparison of Blood Pressure Medications on Metabolism

Phase 4
Completed
Conditions
Diabetes
Interventions
First Posted Date
2008-03-25
Last Posted Date
2023-12-26
Lead Sponsor
University of New Mexico
Target Recruit Count
22
Registration Number
NCT00642434
Locations
🇺🇸

UNMHSC, Albuquerque, New Mexico, United States

Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure

Phase 3
Completed
Conditions
Hypertension
Interventions
First Posted Date
2008-02-26
Last Posted Date
2016-12-28
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
348
Registration Number
NCT00624065
Locations
🇺🇸

GSK Investigational Site, Beloit, Wisconsin, United States

The Preventive Efficacy of Carvedilol on Cardiac Dysfunction in Duchenne Muscular Dystrophy

Phase 4
Conditions
Duchenne Muscular Dystrophy
Cardiomyopathies
Interventions
First Posted Date
2008-02-05
Last Posted Date
2008-02-05
Lead Sponsor
Suzuka Hospital
Target Recruit Count
60
Registration Number
NCT00606775
Locations
🇯🇵

Suzuka Hospial, Suzuka, Mie, Japan

Cocaine Withdrawal and Pharmacotherapy Response

Not Applicable
Completed
Conditions
Opiate Dependence
Cocaine Dependence
Interventions
First Posted Date
2007-12-04
Last Posted Date
2020-04-02
Lead Sponsor
Yale University
Target Recruit Count
106
Registration Number
NCT00566969
Locations
🇺🇸

Veterans Hospital, West Haven, Connecticut, United States

Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components

Phase 1
Completed
Conditions
Hypertension
First Posted Date
2007-11-12
Last Posted Date
2010-10-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
50
Registration Number
NCT00556920
Locations
🇺🇸

GSK Investigational Site, Buffalo, New York, United States

Study to Examine the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination of COREG CR and Lisinopril.

Phase 1
Completed
Conditions
Hypertension
First Posted Date
2007-11-12
Last Posted Date
2010-10-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
24
Registration Number
NCT00557128
Locations
🇺🇸

GSK Investigational Site, Austin, Texas, United States

Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease

Phase 1
Completed
Conditions
Pre-hypertension
Interventions
First Posted Date
2007-11-06
Last Posted Date
2018-04-24
Lead Sponsor
University of Minnesota
Target Recruit Count
101
Registration Number
NCT00553969
Locations
🇺🇸

University of Minnesota, Variety Club Research Center 102, Minneapolis, Minnesota, United States

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