AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (amlodipine besylate) · STRIDES PHARMA INTL
Amlodipine besylate is a calcium channel blocker indicated for the treatment of hypertension to lower blood pressure, thereby reducing the risk of fatal and nonfatal cardiovascular events, such as strokes and myocardial infarctions. It is also indicated for the symptomatic treatment of coronary artery disease (CAD), including chronic stable angina and vasospastic (Prinzmetal’s) angina. Additionally, it is used in patients with angiographically documented CAD (without heart failure or an ejection fraction < 40%) to reduce the risk of hospitalization for angina and to decrease the risk of coronary revascularization procedures. It may be used as monotherapy or in combination with other antihypertensive or antianginal agents.
How AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE Works
Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of extracellular calcium ions into vascular smooth muscle and cardiac muscle cells. By binding to the L-type calcium channels, it inhibits the contractile processes of the muscle cells. Amlodipine acts selectively, with a significantly greater effect on vascular smooth muscle cells than on cardiac muscle cells. This results in peripheral arterial vasodilation, which reduces total peripheral resistance and lowers blood pressure. In patients with angina, amlodipine reduces the total peripheral resistance (afterload) against which the heart works and prevents coronary artery constriction, thereby improving myocardial oxygen delivery and reducing cardiac workload.
Details
- Status
- Prescription
- First Approved
- 2012-09-25
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE Approval History
What AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE Treats
3 indicationsAMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE is approved for 3 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04434664 BLOCK HFpEF results posted | 833517 | Ph 4 | completed | BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF |
| NCT04974138 CSPPT2-CC/CT | CSPPT2-CC/CT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT) |
| NCT04974151 CSPPT2-TT | CSPPT2-TT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype |
| NCT05275907 | STU00215781 1R56HL155093-01 | Ph 4 | withdrawn | Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN) |
| NCT02940548 NARRAS | 2016PHB013-02 | Ph 4 | terminated | Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness |
| NCT01302691 results posted | 0954E-357 | Ph 3 | completed | MK-0954E Study in Participants With Hypertension (MK-0954E-357) |
| NCT02353806 results posted | 042014-059 UL1TR001105 | Ph 4 | completed | Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation |
| NCT01556997 PATH results posted | X985400 | Ph 3 | completed | Perindopril Amlodipine for the Treatment of Hypertension |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE FDA Label Details
Indications & Usage
Amlodipine besylate tablets are calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: •Hypertension о Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. •Coronary Artery Disease о Chronic Stable Angina о Vasospastic Angina (Prinzmetal's or Variant Angina) о Angiographically Documented Coronary Artery Disease in patients without hear...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.