Valsartan: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Valsartan appears in the FDA drug-label database. Marketed as Valsartan.
- Drug class
- Angiotensin 2 Receptor Blocker (FDA established pharmacologic class)
- Mechanism of action
- Angiotensin 2 Receptor Antagonists (as stated on the FDA label)
- Boxed warning
- The FDA label for Valsartan carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2 ) Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal 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 the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets.…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. — Mylan Laboratories Limited, (Nashik FDF) | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2018-12-04 |
| GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. — Mylan Laboratories Limited, (Nashik FDF) | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2018-12-04 |
| GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. — Mylan Laboratories Limited, (Nashik FDF) | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2018-12-04 |
| CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. — Prinston Pharmaceutical Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2018-07-13 |
| CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. — Mylan Pharmaceuticals Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2018-11-20 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Obesity | 2 |
| Essential Hypertension | 1 |
| Healthy Subjects | 1 |
| Heart Dysfunction | 1 |
| Heart Failure | 1 |
| Hypertension | 1 |
| Obesity, Morbid | 1 |
| Overweight Subject | 1 |
Recruiting trials involving Valsartan
- A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
- Bariatric Surgery and Pharmacokinetics of Valsartan
- Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A
- Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
Common questions
Is Valsartan FDA-approved?
Yes, marketed as Valsartan. Its FDA label carries a boxed warning.
How many recruiting trials involve Valsartan?
4 recruiting trials across 8 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.