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Fimasartan/Amlodipine combination
Fimasartan blocks angiotensin II receptors to lower blood pressure, while amlodipine blocks calcium channels to relax blood vessels, providing dual antihypertensive action.
Fimasartan blocks angiotensin II receptors to lower blood pressure, while amlodipine blocks calcium channels to relax blood vessels, providing dual antihypertensive action. Used for Hypertension.
At a glance
| Generic name | Fimasartan/Amlodipine combination |
|---|---|
| Also known as | BR1010 or placebo |
| Sponsor | Boryung Pharmaceutical Co., Ltd |
| 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
Fimasartan is an angiotensin II receptor blocker (ARB) that prevents angiotensin II from binding to AT1 receptors, reducing vasoconstriction and aldosterone secretion. Amlodipine is a dihydropyridine calcium channel blocker that inhibits L-type calcium channels in vascular smooth muscle, causing vasodilation. The combination provides complementary mechanisms for blood pressure reduction.
Approved indications
- Hypertension
Common side effects
- Dizziness
- Headache
- Peripheral edema
- Fatigue
- Hyperkalemia
Key clinical trials
- BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination (PHASE3)
- Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia (PHASE3)
- Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects (PHASE1)
- Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects (PHASE1)
- A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects (PHASE1)
- A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin (PHASE1)
- A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension (PHASE2)
- A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin (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 |