Metoprolol Succinate: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Metoprolol Succinate appears in the FDA drug-label database. Marketed as Metoprolol Succinate.
- Boxed warning
- The FDA label for Metoprolol Succinate carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Metoprolol succinate, is a beta 1 -selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets, USP are indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Angina Pectoris. ( 1.2 ) • Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. ( 1.3 ) 1.1 Hypertension Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will re…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Dissolution Specification — Ascend Laboratories, LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-01-05 |
| Failed Dissolution Specification — Ascend Laboratories, LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-01-05 |
| Failed Dissolution Specification; 12-Month stability interval. — Dr. Reddy's Laboratories, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-12-13 |
| Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. — Dr. Reddy's Laboratories, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2014-05-23 |
| Failed Dissolution Specifications — American Health Packaging | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-12-20 |
Phase breakdown
Conditions being studied
Recruiting trials involving Metoprolol Succinate
- CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
- Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
- Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score
Common questions
Is Metoprolol Succinate FDA-approved?
Yes, marketed as Metoprolol Succinate. Its FDA label carries a boxed warning.
How many recruiting trials involve Metoprolol Succinate?
3 recruiting trials across 11 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.