Drugs / Carvedilol
last change 11 days ago re-read 8 days ago

Carvedilol

Other / unclassified

Developed for
cirrhosis of liver · hypertensive disorder · portal hypertension · heart failure · esophageal varices · essential hypertension · congestive heart failure · atrial fibrillation
+54 more · breast cancer · cardiomyopathy · diastolic heart failure · pulmonary arterial hypertension · chronic obstructive pulmonary disease · heart disorder · HER2 positive breast carcinoma · myocardial infarction · symptomatic heart failure · type 2 diabetes mellitus · cancer · chemotherapy-induced toxicity · coronary artery disorder · diabetes mellitus · dilated cardiomyopathy · Duchenne muscular dystrophy · glioblastoma · hepatic encephalopathy · liver failure · Parkinson disease · pulmonary hypertension · REM sleep behavior disorder · substance-related disorder · abdominal obesity-metabolic syndrome · anxiety · Becker muscular dystrophy · cardiac rhythm disease · cardiomyopathy due to anthracyclines · Chagas cardiomyopathy · cirrhotic cardiomyopathy · epilepsy · esophageal varices with bleeding · Fontan-associated liver disease · hemorrhagic disease · hepatocellular carcinoma · poisoning · prostate cancer · ST-elevation myocardial infarction · strictly posterior acute myocardial infarction · substance dependence · systolic heart failure · univentricular heart · varicose disease · acute coronary syndrome · Alzheimer disease · cocaine dependence · end stage renal failure · esophageal ulcer · non-familial dilated cardiomyopathy · post-traumatic stress disorder · rheumatoid arthritis · substance withdrawal syndrome · traumatic brain injury · tricuspid valve insufficiency
Investigated by
GlaxoSmithKline · Institute of Liver and Biliary Sciences, India · Chong Kun Dang Pharmaceutical · National Cancer Institute (NCI) · University of Minnesota · Seoul National University Bundang Hospital
+213 more · Seoul National University Hospital · Actavis Inc. · American Heart Association · Beijing Friendship Hospital · Bispebjerg Hospital · Chengdu Shangjin Nanfu Hospital · Jiangsu HengRui Medicine Co., Ltd. · Keimyung University Dongsan Medical Center · Mayo Clinic · Mylan Pharmaceuticals Inc · National Heart, Lung, and Blood Institute (NHLBI) · National Institute on Drug Abuse (NIDA) · Samsung Medical Center · Shaddy, Robert, M.D. · Shanghai Zhongshan Hospital · St. Paul Heart Clinic · Teva Pharmaceuticals USA · University of Alabama at Birmingham · Virginia Commonwealth University · Weill Medical College of Cornell University · West China Hospital · West China Tianfu Hospital · West Virginia Clinical and Translational Science Institute · West Virginia University · Wonju Severance Christian Hospital · Aalborg University Hospital · Aarhus University Hospital · Aaron J. Janowsky · Abbott Medical Devices · Abramson Cancer Center at Penn Medicine · Aga Khan University · Albert Einstein College of Medicine · Amager Hospital · American Diabetes Association · American Epilepsy Society · Andhra Medical College · Assistance Publique Hopitaux Paris AVICENNE · Assistance Publique Hopitaux Paris BEAUJON · Assistance Publique Hopitaux Paris HENRI MONDOR · Assistance Publique Hopitaux Paris PAUL BROUSSE · Assistance Publique Hopitaux Paris ST ANTOINE · AstraZeneca · Bornholm Hospital · Brighton and Sussex University Hospitals NHS Trust · Cairo University · Cardiff University · Cardiovascular Clinical Sciences Inc · Catholic University, Italy · Cedars-Sinai Medical Center · Centre Hospitalier Régional Universitaire Lille · Centre Hospitalier Universitaire Amiens Picardie · Centre Hospitalier Universitaire Clermont Ferrand · Centre Hospitalier Universitaire Dijon · Centre Hospitalier Universitaire Grenoble · Centre Hospitalier Universitaire Haut Lévêque · Centre Hospitalier Universitaire Jean Minjoz · Centre Hospitalier Universitaire Pontchaillou · Centre Hospitalier Universitaire de Caen · Centre Hospitalier intercommunal de Créteil · Centre Hospitaliser Départemental de Vendée · Centro Hospitalar De São João, E.P.E. · Changqing Yang · Children's Oncology Group · Chinese University of Hong Kong · Chonbuk National University Hospital · Chongqing Qianjiang Central Hospital · Chonnam National University Hospital · Chosun University Hospital · Chungbuk National University Hospital · Chungnam National University Hospital · Columbia University · Creighton University · Danish Center for Sleep Medicine · Danish Heart Foundation · all 219 on the full record

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (6) US (FDA) COREG — 1997-05-29 – 2007-02-23 fda.gov ↗
Approved US (FDA) COREG — 1995-09-14 fda.gov ↗

Trials 136 · started per year

today
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1995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT03980249 Sep 2020 → Dec 2021 glioblastoma West Virginia University Withdrawn No outcome recorded Stop: Business
Phase 0 NCT03861598 Jul 2019 → Aug 2020 glioblastoma West Virginia University Terminated No outcome recorded
Phase 0 NCT03576664 Aug 2018 → Sep 2019 sleep-wake disorder Gitte Moos Knudsen Completed No outcome recorded
Phase 119 trials · 2 met primary
Phase 1 NCT04023110 Aug 2019 → Aug 2024 breast cancer, cardiomyopathy, chemotherapy-induced toxicity, heart failure Abramson Cancer Center at Penn Medicine Completed No outcome recorded
Phase 1 NCT02286934 Sep → Nov 2014 — Seoul National University Hospital Completed No outcome recorded
Phase 1 NCT02120339 May 2014 → Jun 2015 pulmonary hypertension University of Minnesota Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT01793870 Jan → Jun 2013 cardiovascular-kidney-metabolic syndrome GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01568645 Mar → Dec 2012 pulmonary hypertension National Heart, Lung, and Blood Institute (NHLBI) Withdrawn No outcome recorded
Phase 1 NCT01340248 Jul → Aug 2011 intermediate coronary syndrome Chong Kun Dang Pharmaceutical Completed No outcome recorded
Phase 1 NCT00742508 Aug 2008 → Aug 2009 congestive heart failure GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00557128 Nov → Dec 2007 hypertensive disorder GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00549510 Oct → Dec 2007 hypertensive disorder GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00537043 Oct 2007 → Jan 2008 essential hypertension GlaxoSmithKline Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT05194111 Aug 2022 → Nov 2028 expected heart failure Virginia Commonwealth University Recruiting No outcome recorded
Phase 1/2 NCT03361280 Feb 2015 → Mar 2016 chronic kidney disease London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Completed No outcome recorded
Phase 1/2 NCT01723371 Sep 2012 → Sep 2015 pulmonary arterial hypertension The Hospital for Sick Children Withdrawn No outcome recorded Stop: Enrollment
Phase 1/2 NCT00964678 Jun 2010 → May 2014 pulmonary arterial hypertension Virginia Commonwealth University Completed No outcome recorded
Phase 1/2 NCT00553969 Nov 2007 → Sep 2010 hypertensive disorder University of Minnesota Completed No outcome recorded
Phase 217 trials · 2 missed
Phase 2 NCT07350070 Dec 2025 → Jun 2027 expected cirrhosis of liver, hepatocellular carcinoma, portal hypertension Tongji Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06844669 Apr 2025 → Feb 2026 HER2 positive breast carcinoma Washington University School of Medicine Terminated No outcome recorded
Phase 2 NCT04977180 Mar 2022 → Mar 2028 expected acute myeloid leukemia University of Virginia Recruiting No outcome recorded
Phase 2 NCT04218968 Dec 2019 → Jun 2026 overdue Parkinson disease, REM sleep behavior disorder Cedars-Sinai Medical Center Active not recruiting No outcome recorded
Phase 2 NCT03879629 Aug 2019 → Feb 2026 breast cancer Mayo Clinic Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03538015 Apr 2019 → Aug 2020 — Owen Chan, PhD Terminated No outcome recorded Stop: Business
Phase 2 NCT03775096 Apr 2019 → Jul 2026 overdue Parkinson disease, REM sleep behavior disorder Michele Tagliati, MD Active not recruiting No outcome recorded
Phase 2 NCT02944201 Apr 2017 → Dec 2020 prostate cancer Montefiore Medical Center Unknown No outcome recorded
Phase 2 NCT02717507 Apr 2016 → Jun 2022 cancer, hematopoietic and lymphoid cell neoplasm Children's Oncology Group Completed Missed primary
Phase 2 NCT03867994 Feb 2016 → May 2017 — rabab ahmed mohamed Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT04499898 Oct 2018 → Dec 2030 expected esophageal varices Tanta University Recruiting No outcome recorded
Phase 2/3 NCT00524134 Dec 2008 → Oct 2010 epilepsy Columbia University Terminated No outcome recorded
Phase 319 trials · 1 met primary · 4 missed
Phase 3 NCT06263816 Jun 2025 → Jul 2027 expected cirrhosis of liver, portal hypertension University Hospital, Tours Not yet recruiting No outcome recorded
Phase 3 NCT04543643 Nov 2021 → Oct 2023 esophageal varices, hepatitis C induced liver cirrhosis Tianjin Second People's Hospital Unknown No outcome recorded
Phase 3 NCT04121299 Jul 2021 → Jun 2026 hypertensive disorder University of Alabama at Birmingham Withdrawn No outcome recorded Stop: Business
Phase 3 NCT03542058 Jun 2018 → Jun 2021 cardiomyopathy due to anthracyclines Makerere University Unknown No outcome recorded
Phase 3 NCT03418961 Nov 2017 → Sep 2027 expected HER2 positive breast carcinoma, chemotherapy-induced toxicity, metastatic malignant neoplasm in the brain SWOG Cancer Research Network Recruiting No outcome recorded
Phase 3 NCT02975323 Dec 2014 → Jun 2017 portal hypertension Aga Khan University Unknown No outcome recorded
Phase 3 NCT02012075 Dec 2013 → Feb 2015 heart failure Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 3 NCT01970059 Oct 2013 essential hypertension Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 3 NCT01756430 Dec 2012 → Sep 2013 essential hypertension Chong Kun Dang Pharmaceutical Completed No outcome recorded
Phase 3 NCT01178528 Sep 2009 → Jun 2010 heart failure IRCCS San Raffaele Completed No outcome recorded
Phase 445 trials · 4 met primary · 4 missed
Phase 4 NCT06964464 Aug 2025 → Jun 2031 expected cardiomyopathy, sudden cardiac arrest, systolic heart failure University of Rochester Recruiting No outcome recorded
Phase 4 NCT06449339 Jul 2024 → Jul 2031 expected portal hypertension Chinese University of Hong Kong Recruiting No outcome recorded
Phase 4 NCT06035978 Mar 2024 → Apr 2026 symptomatic heart failure University Hospital Ostrava Unknown No outcome recorded
Phase 4 NCT05585125 Feb 2024 → Jul 2026 overdue diastolic heart failure Weill Medical College of Cornell University Enrolling by invitation No outcome recorded
Phase 4 NCT05019027 Jan 2024 → Mar 2026 overdue amyloidosis, heart disorder Weill Medical College of Cornell University Enrolling by invitation No outcome recorded
Phase 4 NCT05637853 Oct 2022 → Aug 2024 overdue symptomatic heart failure Göteborg University Active not recruiting No outcome recorded
Phase 4 NCT05553314 Nov 2021 → Jan 2026 diastolic heart failure Seoul National University Bundang Hospital Completed No outcome recorded
Phase 4 NCT05179070 Sep 2021 → Feb 2022 heart failure Universitas Sebelas Maret Unknown No outcome recorded
Phase 4 NCT04939883 Aug 2021 → May 2027 expected cancer Hospital Sirio-Libanes Active not recruiting No outcome recorded
Phase 4 NCT04769362 May 2021 → Jan 2026 overdue myocardial infarction Samsung Medical Center Recruiting Met primary
Phase not applicable26 trials · 3 met primary · 1 missed
— NCT07587671 Aug 2026 → Mar 2029 expected cirrhosis of liver, esophageal varices with bleeding, hepatic encephalopathy, portal hypertension West China Hospital Not yet recruiting No outcome recorded
— NCT07577518 Jun 2026 → Apr 2030 expected coronary artery disorder Seoul National University Hospital Not yet recruiting No outcome recorded
— NCT07465471 Mar 2026 → Sep 2027 expected cirrhosis of liver Institute of Liver and Biliary Sciences, India Not yet recruiting No outcome recorded
— NCT06861075 Apr 2025 → Mar 2028 expected cirrhosis of liver, portal hypertension University Hospital, Clermont-Ferrand Recruiting No outcome recorded
— NCT05699824 Jul 2023 → Jun 2024 cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT06015373 Jun 2023 portal hypertension Centro Hospitalar De São João, E.P.E. Completed No outcome recorded
— NCT05767229 Mar 2023 → Nov 2024 portal hypertension Institute of Liver and Biliary Sciences, India Completed No outcome recorded
— NCT05651789 Jan 2023 → Dec 2024 cirrhosis of liver, portal hypertension, varicose disease West China Hospital Unknown No outcome recorded
— NCT05180292 Jan 2022 → Dec 2024 liver failure Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT05057572 Oct 2021 → Dec 2023 cirrhosis of liver Institute of Liver and Biliary Sciences, India Completed Met primary
Comparator or background therapy86 trials
Phase 0 NCT06108518 Comparator Jun → Oct 2024 rheumatoid arthritis Tanta University Unknown No outcome recorded
Phase 0 NCT06643221 Comparator Jan 2018 → May 2031 expected leukemia, lymphoma University of Arizona Recruiting No outcome recorded
Phase 1 NCT06304896 Comparator May 2024 → May 2025 chemotherapy-induced toxicity Arab Contractors Medical Centre Unknown No outcome recorded
Phase 1 NCT02907021 Background Nov 2016 → Apr 2018 breast cancer, heart failure Population Health Research Institute Completed No outcome recorded
Phase 1/2 NCT06836856 Comparator Jan → Jun 2025 overdue traumatic brain injury Mansoura University Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2017-12-08 Impax Laboratories, LLC Regulatory Impax Receives Tentative FDA Approval of Generic Coreg CR® (Carvedilol Phosphate) Extended-Release Capsules amneal.com ↗
today announced it has received tentative U.S. Food and Drug Administration (" FDA ") approval on its Abbreviated New Drug Application ("ANDA") for a generic version of Coreg CR ® (carvedilol phosphate) extended-release capsules, 10, 20, 40 and 80 mg.
2017-10-26 Sun Pharmaceutical Industries, Inc. Regulatory Sun Pharma announces US FDA approval for generic Coreg CR® sunpharma.com ↗
2007-09-06 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval And Shipment Of Generic Coreg® Tablets tevapharm.com ↗
the U.S. Food and Drug Administration (FDA) has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its Generic version of GlaxoSmithKline's cardiovascular agent Coreg® (Carvedilol) Tablets
2004-06-09 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Tentative Approval Of Carvedilol Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg.

All press releases naming this drug 5 releases

DateIssuerRelease

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 225 sources stand behind the page.

FieldValueCited text
Known as Carvedilol “The pharmacological treatment intended to enhance reverse remodeling includes 4 drugs initiated immediately after weaning of inotropic support once achieving adequate end-organ...” NCT01774656 ↗
217

“The purpose of this research study is to determine whether Carvedilol, an FDA approved beta blocker, when administered for an 8-week period to veterans currently undergoing...” NCT00442923 ↗

“Randomisation will be stratified according to the type of AMI (ie, ST-segment-elevation MI or non-ST-segment-elevation MI), type of β-blocker (carvedilol, bisoprolol, nebivolol...” PMID 39645270 ↗ Aug 2024

“Other names: acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol,...” NCT05585125 ↗

“Other Names: * acebutolol * atenolol * betaxolol * bisoprolol * carvedilol * labetalol * metoprolol succinate * metoprolol tartrate * nadolol * nebivolol * penbutolol *...” NCT05019027 ↗

“including the beta-blocker, carvedilol, and the ACE-I, ramipril, as tolerated, at the maximum doses tolerated, up to carvedilol 25mg BID and ramipril 10mg once daily” NCT02907021 ↗

“All patients will be started on an SGLT2i (Empagliflozin or Dapagliflozin) and a betablocker (Metoprolol, Bisoprolol or Carvedilol) right after study inclusion.” NCT05637853 ↗

“Carvedilol will be the preferred nonselective beta-blocker, starting at 6.25 mg once daily and increasing to 12.5 mg once daily after 1 week if tolerated.” NCT07587671 ↗

“Significant reduction of portal pressure is observed in up to 50% of patients treated with propranolol and up to 75% with carvedilol.” NCT07111221 ↗

“Carvedilol Combined With Ivabradine Improves Left Ventricular Diastolic Dysfunction, Clinical Progression, and Survival in Cirrhosis.” PMID 31305281 ↗ Jul 2020

“The beta-blocker agent may include atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate.” NCT07298993 ↗

Show 207 more sources

Known as carvedilol (Coreg) “carvedilol (Coreg)” NCT00000620 ↗
Known as Carvedilol Controlled Release (CR) “Drug: Carvedilol Controlled Release (CR)” NCT00430040 ↗
Known as carvedilol CR “Initial dose: Carvedilol CR (20 mg QD, dose level 1) Titration: If tolerated, increase the dosage to 20 mg QD, 40 mg QD, and 80mg QD orally over successive intervals of at...” NCT00430040 ↗
3

“Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.” NCT00524134 ↗

“once-daily extended-release carvedilol (carvedilol CR) combined with the ACEI lisinopril” PMID 20883227 ↗ Jul 2010

“Drug: Carvedilol CR” NCT00657241 ↗

Known as carvedilol slow-release (SR) “carvedilol slow-release (SR)” NCT05553314 ↗
Known as carvedilol-SR “The objective of this trial is to evaluate the effect of sustained-release carvedilol (carvedilol-SR) on the outcome [N-terminal pro-B-natriuretic peptide (NT-proBNP)...” PMID 38737708 ↗ Apr 2024
Known as Carvid “Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®” NCT05849766 ↗
1

“Carvid (carvedilol)” NCT06836856 ↗

Known as COREG “The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5 mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x...” NCT00650416 ↗
7

“The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12.5 mg tablets to GSK's Coreg® 12.5 mg tablets following a single, oral 12.5 mg (1 x...” NCT00648622 ↗

“The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release...” NCT00272805 ↗

“Carvedilol, sold under the brand name Coreg among others, is a medication used to treat high blood pressure, congestive heart failure, and left ventricular dysfunction in...” NCT05872698 ↗

“The carvedilol micropump (COREG) CR cpsules will be available with doses of 20 milligrams and 40 milligrams administered orally once daily.” NCT00508365 ↗

“mortality benefits (carvedilol \[Coreg\] 25 mg bid, metoprolol succinate \[Toprol-XL\] 200 mg qd)” NCT00433043 ↗

“commercially available carvedilol (COREG®, SmithKline Beecham Pharmaceuticals)” NCT00834873 ↗

“commercially available carvedilol (COREG®, SmithKline Beecham Pharmaceuticals)” NCT00834795 ↗

Known as COREG CR “20mg, 40mg, or 80mg QD Doses of Carvedilol Controlled Release Formulation (COREG CR)” NCT00347360 ↗
3

NCT00557128 ↗

NCT00549510 ↗

NCT01009918 ↗

Known as CVD “CECCY trial demonstrated that the β-blocker carvedilol (CVD) could attenuate myocardial injury secondary to ANT.” PMID 35087624 ↗ Jan 2022
Known as Dilatrend “Carvedilol (Dilatrend) tablet will be administered orally to patients according to their clinical condition and the decision of the attending physician.” NCT06035978 ↗
1

NCT01340248 ↗

Known as Dilatrend SR “Carvedilol SR (Dilatrend SR; 8/16/32/64 mg) once daily, starting at 32 mg and up-titrated to maximal tolerated dose (up to 128 mg).” NCT07577518 ↗
Known as Dilatrend Tab “Dilatrend Tab® (carvedilol) 12.5 mg” NCT00496834 ↗
Action Inhibit “blockage of adrenergic receptors by carvedilol” NCT00000294 ↗
Modality Other / unclassified “Carvedilol and bisoprolol are established beta-blockers for treating hypertension or chronic heart failure” NCT01243827 ↗
Route Oral “a single oral dose of low (25mg) or high dose of carvedilol (50mg)” NCT00000294 ↗