Carvedilol: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Carvedilol appears in the FDA drug-label database. Marketed as Carvedilol.
- Drug class
- alpha-Adrenergic Blocker; beta-Adrenergic Blocker (FDA established pharmacologic class)
- Mechanism of action
- Adrenergic alpha-Antagonists; Adrenergic beta1-Antagonists; Adrenergic beta2-Antagonists (as stated on the FDA label)
FDA-approved use
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients( 1.2 ) hypertension( 1.3 ) 1.1 Heart Failure Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions ( 7.4 ), Clinical Studies ( 14.1 )] . 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2 )] . 1.3 Hypertension Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies ( 14.3 , 14.4 )] . It can be used alone or in combination with other antihypertensive agents, especially…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-02-28 |
| CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-02-28 |
| CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-08-07 |
| CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-01-22 |
| CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-01-22 |
Phase breakdown
Conditions being studied
Recruiting trials involving Carvedilol
- Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
- CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound
- CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
- Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding
- Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
- DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
- Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC
- Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
- S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
- Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
Common questions
Is Carvedilol FDA-approved?
Yes, marketed as Carvedilol.
How many recruiting trials involve Carvedilol?
10 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.