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Irbesartan/Amlodipine high
This combination drug blocks angiotensin II receptors and calcium channels to reduce blood pressure through dual vasodilation and reduced vascular resistance.
This combination drug blocks angiotensin II receptors and calcium channels to reduce blood pressure through dual vasodilation and reduced vascular resistance. Used for Hypertension.
At a glance
| Generic name | Irbesartan/Amlodipine high |
|---|---|
| Sponsor | Handok Inc. |
| Drug class | Angiotensin II receptor blocker / Calcium channel blocker combination |
| Target | AT1 receptor / L-type calcium channel |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Irbesartan is an angiotensin II receptor blocker (ARB) that prevents angiotensin II from binding to AT1 receptors on blood vessels and the heart, causing vasodilation and reduced aldosterone secretion. Amlodipine is a dihydropyridine calcium channel blocker that inhibits calcium influx into vascular smooth muscle cells, further promoting vasodilation. Together, these complementary mechanisms provide additive blood pressure reduction.
Approved indications
- Hypertension
Common side effects
- Dizziness
- Peripheral edema
- Fatigue
- Headache
- Hyperkalemia
Key clinical trials
- Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension
- Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients (PHASE3)
- Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers (PHASE1)
- Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers (PHASE1)
- Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients (PHASE3)
- Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension (PHASE2)
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/Amlodipine high CI brief — competitive landscape report
- Irbesartan/Amlodipine high updates RSS · CI watch RSS
- Handok Inc. portfolio CI