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Data updated: May 26, 2026

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (hydrochlorothiazide)

Cardiovascular Approved 1979-08-03
Jump to: Indications Approvals Trials Competitors Safety Patents
7
Indications
--
Phase 3 Trials
46
Years on Market

Details

Status
Discontinued
First Approved
1979-08-03
Routes
ORAL
Dosage Forms
TABLET

Companies

CHARTWELL RX PUREPAC PHARM Sun Pharma ASCOT SUPERPHARM MUTUAL PHARM Viatris WATSON LABS
Active Ingredient: HYDROCHLOROTHIAZIDE , SPIRONOLACTONE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Approval History

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Original
New Indication
New Form
Label Update
122 FDA actions from 1979 to 2026
May 2026 SUPPL
Label · Labeling
Dec 2024 SUPPL
Label · Labeling
May 2023 SUPPL
Label · Labeling

What SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Treats

7 FDA approvals

Originally approved for its first indication in 1979 . Covers 7 distinct patient populations.

  • Other (7)
📋

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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE FDA Label Details

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Data Sources

FDA Approval: ANDA086881 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.