BENICAR HCT (hydrochlorothiazide)
BENICAR HCT is indicated for the treatment of Hypertension.
How BENICAR HCT Works
Benicar HCT combines two antihypertensive agents with complementary mechanisms. Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the $AT_1$ receptor in vascular smooth muscle, inhibiting its vasoconstrictor effects. Hydrochlorothiazide is a thiazide diuretic that acts on the renal tubular mechanisms of electrolyte reabsorption, directly increasing the excretion of sodium and chloride. This diuretic action reduces plasma volume and decreases peripheral vascular resistance, further lowering blood pressure.
Details
- Status
- Prescription
- First Approved
- 2003-06-05
- Routes
- ORAL
- Dosage Forms
- TABLET
BENICAR HCT Approval History
What BENICAR HCT Treats
1 indicationsBENICAR HCT is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
BENICAR HCT Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue BENICAR HCT as soon as possible [see Warnings and Precautions (5.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue BENICAR HCT as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can ...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue BENICAR HCT as soon as possible [see Warnings and Precautions (5.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue BENICAR HCT as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ).
BENICAR HCT 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.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 BENICAR HCT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BENICAR HCT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BENICAR HCT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
45 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03892148 ProDUCT-HF | CHU-428 2018-A02971-54 | Ph 4 | completed | Protocol of Diuretics Use in Congestive Therapy in Heart Failure |
| NCT04654312 | HCTox | Ph 1 | completed | Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study (HCTox Study) |
| NCT02373163 INTERVENCION results posted | INTERVENCION Trial | Ph 4 | completed | INTERVENCION Trial |
| NCT03109795 ATLAS results posted | 201701762 | Ph 4 | terminated | Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System |
| NCT05917275 HT-PREDICT | 114516 2023-505239-10-00 | Ph 4 | recruiting | Multi-Omics to Predict the Blood Pressure Response to Antihypertensives |
| NCT03179163 H2SPharm results posted | STUDY3224 5R01HL093238, 120058 | Ph 1, Ph 2 | terminated | Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvessels in Humans |
| NCT01983462 VANISH results posted | 201307779 | Ph 2 | terminated | Vascular Dysfunction in Human Obesity Hypertension |
| NCT01647932 CLOROTIC | SEMI-IC-CLOR | Ph 3 | completed | Safety and Efficacy of the Combination of Loop With Thiazide-type Diuretics in Patients With Decompensated Heart Failure |
| NCT03461003 NICHE results posted | HSC-MS-17-1014 UL1TR003167 | Ph 4 | completed | N-of-1 Trials In Children With Hypertension |
| NCT03387657 | INT14905 U1111-1186-2718 | Ph 1 | completed | A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide |
| NCT00667719 results posted | CSAH100A2301 2008-001242-10 | Ph 3 | completed | A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension |
| NCT02699125 guanhctz results posted | guanhctz | Ph 4 | completed | Treatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic |
| NCT02710071 nebhctz results posted | 110342 | Ph 4 | completed | Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide |
| NCT03170336 ANTI-UPRO | GGH2016422H | Ph 4 | completed | A New Application of Amiloride in the Treatment of Patient With Chronic Kidney Disease In Reducing Urinary PROtein |
| NCT00765947 results posted | CSPP100A2360 | Ph 4 | completed | Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension |
| NCT01519635 results posted | 2011DR3137 | Ph 4 | completed | Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension |
| NCT04197622 HCTZ | IMIMFTCL/HCTZ | Ph 1 | completed | Generation of Biological Samples Positive to Hydrochlorothiazide for Anti-doping Control |
| NCT03889145 | ID-TAH-1301 | Ph 1 | completed | A Study to Evaluate the Drug-drug Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide |
| NCT00649389 results posted | CS8635-A-U301 | Ph 3 | completed | Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension |
| NCT02875886 DD | NL54748.078.15 | Ph 4 | completed | DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease |
| NCT00994253 | 2009-083 | Ph 4 | withdrawn | Evaluating the Effect of Aliskiren Versus HCTZ on Coronary Flow Reserve in Hypertensive Type II Diabetics |
| NCT01748123 | PCORI-EGID 4231 00041242 | Ph 4 | withdrawn | EBMtrialcentral- Comparing Initial Diuretic Therapies Using a Collaborative Network |
| NCT00976495 results posted | MB102-035 EUDRACT #: 2009-010221-39 | Ph 2 | completed | Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes |
| NCT02739672 | ID-TAH-102 | Ph 1 | completed | Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers |
| NCT03032315 | ID-TAH-103 | Ph 1 | completed | Compare the Pharmacokinetics of TAH(80/10/12.5) Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers |
| NCT01975246 results posted | 1348.1 | Ph 3 | completed | Add-on to Micamlo BP Trial |
| NCT01365481 results posted | CVAL489K2305 2009-017594-37 | Ph 3 | completed | Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age |
| NCT02222480 | BR-FHC-CT-201-BZ | Ph 2 | completed | A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide |
| NCT01692301 results posted | CLCZ696A2216 2012-002899-14 | Ph 2 | completed | Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension |
| NCT01480791 | CSPP100ACA03T | Ph 2 | withdrawn | Aliskiren vs Hydrochlorothiazide in Hypertensive Type II Diabetic Patients on Resistance Arteries |
| NCT01922141 ASSESS | CSPP100A2370 2013-001562-42 | Ph 4 | withdrawn | Aliskiren Study of Safety and Efficacy in Senior Hypertensives |
| NCT01276288 results posted | 1245.42 2010-019624-31 | Ph 1 | completed | Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes |
| NCT00926289 results posted | 502.550 2008-007711-32 | Ph 4 | completed | Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension |
| NCT01172431 | WestChinaH | Ph 4 | completed | Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency |
| NCT02072330 | TAK-536TCH/CCT-001 JapicCTI-121962 | Ph 2, Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension. |
| NCT00605072 AVEC results posted | IA0127 K23AG030057 | Ph 2 | completed | The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial |
| NCT01138423 TARGET | UMCU-Vasc-14A | Ph 4 | completed | Treatment of Adiposity Related hypErTension (TARGET) |
| NCT00797862 ACCELERATE results posted | CSPA100A2307 | Ph 3 | completed | Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension |
| NCT00980187 AISHA | RO-SCL-IQ v 1.0/04.07 | Ph 4 | completed | A Comparison of Indapamide SR 1.5 mg With HCTZ 25 mg, in Combination With an ACE-inhibitor, in Patients With Mild to Moderate AHT and Type 2 DM |
| NCT00760266 ACTION results posted | CSPP100A2411 | Ph 4 | completed | Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population |
| NCT00797316 AIMS results posted | CSPP100A2410 | Ph 4 | completed | Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension |
| NCT00654745 results posted | CS-8663-403 | Ph 4 | completed | 18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics |
| NCT00621153 CAESAR results posted | D2452L00016 | Ph 4 | completed | Candesartan Effect in Second Stage Arterial Hypertension |
| NCT00605202 results posted | Lakritsi ja hypokalemia | Ph 4 | completed | Effect of Licorice and Hydrochlorothiazide on Plasma Potassium |
| NCT00923533 | A657-BR-CT-103 | Ph 1 | completed | A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers |
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.
BENICAR HCT FDA Label Details
Indications & Usage
FDA Label (PDF)BENICAR HCT is indicated for the treatment of Hypertension.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue BENICAR HCT as soon as possible [see Warnings and Precautions (5.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TO...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.