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Irbesartan/Atorvastatin A
Irbesartan/Atorvastatin is a fixed-dose combination that lowers blood pressure via angiotensin II receptor blockade and reduces cholesterol via HMG-CoA reductase inhibition.
Irbesartan/Atorvastatin is a fixed-dose combination that lowers blood pressure via angiotensin II receptor blockade and reduces cholesterol via HMG-CoA reductase inhibition. Used for Hypertension with dyslipidemia, Cardiovascular risk reduction in patients requiring both antihypertensive and lipid-lowering therapy.
At a glance
| Generic name | Irbesartan/Atorvastatin A |
|---|---|
| Also known as | HCP0912 A |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Drug class | Angiotensin II receptor blocker / HMG-CoA reductase inhibitor combination |
| Target | AT1 receptor / HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Irbesartan blocks the angiotensin II type 1 receptor, causing vasodilation and reducing blood pressure. Atorvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby lowering LDL cholesterol and triglycerides. Together, the combination addresses two major cardiovascular risk factors in a single formulation.
Approved indications
- Hypertension with dyslipidemia
- Cardiovascular risk reduction in patients requiring both antihypertensive and lipid-lowering therapy
Common side effects
- Dizziness
- Fatigue
- Muscle pain (myalgia)
- Elevated liver enzymes
- Hyperkalemia
Key clinical trials
- Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia (PHASE4)
- Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA) (PHASE4)
- Renal Denervation in Diabetic Nephropathy (PHASE4)
- Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia (PHASE3)
- A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Irbesartan/Atorvastatin A CI brief — competitive landscape report
- Irbesartan/Atorvastatin A updates RSS · CI watch RSS
- Hanmi Pharmaceutical Company Limited portfolio CI