Ramipril: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Ramipril appears in the FDA drug-label database. Marketed as Ramipril.
- Drug class
- Angiotensin Converting Enzyme Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Angiotensin-converting Enzyme Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for Ramipril carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
. INDICATIONS AND USAGE • Ramipril capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. ( 1.1 ). • Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3 ). 1.1 Hypertension Ramipril capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. 1.3 Heart Failure Post-Myocardial Infarction Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure [see CLINICAL STUDIES ( 14.3 ) ].
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor — Lupin Pharmaceuticals Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2024-10-23 |
| CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor — Lupin Pharmaceuticals Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2024-10-23 |
| CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor — Lupin Pharmaceuticals Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2024-10-23 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Heart failure | 2 |
| Chronic Kidney Disease | 1 |
| Heart Failure With Moderately Reduced Ejection Fraction | 1 |
| Heart Failure With Reduced Ejection Fraction (HFrEF) | 1 |
| Obesity | 1 |
| Obesity, Morbid | 1 |
Recruiting trials involving Ramipril
- Bariatric Surgery and Pharmacokinetics of Ramipril
- Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Disease Patients With Reduced Ejection Fraction Heart Failure
- The Effect of Sacubitril/Valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients With Ischemic Heart Failure With Mid-range Ejection Fraction
Common questions
Is Ramipril FDA-approved?
Yes, marketed as Ramipril. Its FDA label carries a boxed warning.
How many recruiting trials involve Ramipril?
3 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.