LISINOPRIL AND HYDROCHLOROTHIAZIDE (hydrochlorothiazide)
This combination medication treats high blood pressure to help patients reduce their risk of serious cardiovascular events like strokes and heart attacks. It is often used for individuals who require more than one medication to reach their blood pressure goals. By managing hypertension, the drug serves as a key component of a broader strategy to protect long-term heart and vascular health.
How LISINOPRIL AND HYDROCHLOROTHIAZIDE Works
This drug works by inhibiting the angiotensin-converting enzyme (ACE), which prevents the formation of a substance that narrows blood vessels. This process also decreases the secretion of aldosterone, leading to reduced blood pressure and a slight increase in potassium levels. The addition of a thiazide diuretic further assists in blood pressure management and helps maintain stable potassium levels.
Details
- Status
- Prescription
- First Approved
- 2002-07-01
- Routes
- ORAL
- Dosage Forms
- TABLET
LISINOPRIL AND HYDROCHLOROTHIAZIDE Approval History
What LISINOPRIL AND HYDROCHLOROTHIAZIDE Treats
3 indicationsLISINOPRIL AND HYDROCHLOROTHIAZIDE is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Stroke
- Myocardial Infarction
LISINOPRIL AND HYDROCHLOROTHIAZIDE Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue lisinopril and hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings, Fetal Toxicity ....
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue lisinopril and hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings, Fetal Toxicity .
LISINOPRIL 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.
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 LISINOPRIL AND HYDROCHLOROTHIAZIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LISINOPRIL AND HYDROCHLOROTHIAZIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LISINOPRIL AND HYDROCHLOROTHIAZIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
70 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| NCT03892148 ProDUCT-HF | CHU-428 2018-A02971-54 | Ph 4 | completed | Protocol of Diuretics Use in Congestive Therapy in Heart Failure |
| NCT04550481 | NCI-2020-06905 NCI-2020-06905, NCI20-01-03 | Ph 2 | active not recruiting | Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study |
| NCT05056727 STABILIZE-CKD results posted | D9488C00001 2021-001911-96 | Ph 3 | terminated | A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia |
| NCT02847338 AIMHY-INFORM | AO94005 | Ph 4 | completed | Comparison of Optimal Hypertension Regimens |
| 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 |
| NCT03201939 R3 results posted | Vanderbilt_University MC U01DK112271 | Ph 2 | terminated | Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria |
| NCT06772779 | 0616-026 MK-0616-026 | Ph 1 | completed | A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026) |
| 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 |
| NCT03392740 | GHIGHCI2018 | Ph 4 | withdrawn | Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy. |
| NCT03179163 H2SPharm results posted | STUDY3224 5R01HL093238, 120058 | Ph 1, Ph 2 | terminated | Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvessels in Humans |
| NCT04190433 | 19-007547 NCI-2021-13928 | Ph 2 | withdrawn | Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial |
| 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 |
| NCT01009918 results posted | SCUSF 0806 SCUSF-0806, 5U10CA081920-11 | Ph 2 | completed | Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab |
| NCT01984164 CALIBREX results posted | IRB00070087 R01AG042127 | Ph 2 | completed | CAndesartan vs LIsinopril Effects on the BRain |
| NCT02699125 guanhctz results posted | guanhctz | Ph 4 | completed | Treatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic |
| NCT00874432 results posted | H-2008-0221 A534280, SMPH/MEDICINE/NEPHROLOGY | Ph 2 | completed | Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease |
| 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 |
| NCT01837069 OPTMIZE-OS results posted | 12-02407 | Ph 4 | terminated | Risk Factor Control Before Orthopedic Surgery |
| NCT01519635 results posted | 2011DR3137 | Ph 4 | completed | Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension |
| NCT02070510 | NN9924-4065 2013-001087-39, U1111-1140-3741 | Ph 1 | completed | A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects |
| NCT01880528 results posted | MC1221 NCI-2013-01139, 12-008062 | Ph 2 | completed | Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer |
| 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 |
| NCT01234922 results posted | IRB00014933 NCI-2010-02043, IRB00014933 | Ph 2 | terminated | Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors |
| 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 |
| NCT01066572 PIL-FAST | RP-PG-0606-1241 | Ph 1 | completed | Paramedic Initiated Lisinopril For Acute Stroke Treatment |
| 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 |
| NCT02641899 | ITCA 650-CLP-115 | Ph 1 | completed | Study of the Effects of ITCA 650 on Gastric Emptying and Interaction of ITCA 650 on 4 Commonly Studied Drugs |
| 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 |
| NCT01398267 | BP25328 | Ph 1 | completed | A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril |
| 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 |
| NCT01535235 results posted | 11-08132 | Ph 4 | completed | ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study |
| 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 |
| NCT01491919 PTN_LISINO results posted | Pro00029537 HHSN275201000003I | Ph 1 | completed | Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant |
| NCT00555217 VA NEPHRON-D results posted | 565 | Ph 3 | terminated | VA NEPHRON-D: Diabetes iN Nephropathy Study |
Showing 50 of 70 trials
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.
LISINOPRIL AND HYDROCHLOROTHIAZIDE FDA Label Details
Indications & Usage
LISINOPRIL AND HYDROCHLOROTHIAZIDE is indicated for the treatment of Hypertension; Stroke; Myocardial Infarction.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue lisinopril and hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings, Fetal Toxicity ....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.