Drugs / Chlorthalidone
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Chlorthalidone

Other / unclassified

Developed for
hypertensive disorder · essential hypertension · chronic kidney disease · heart failure · obstructive sleep apnea syndrome · end stage renal failure · idiopathic hypercalciuria · nephrolithiasis, calcium oxalate
+5 more · resistant hypertension · secondary hypertension · urolithiasis · arteriosclerosis disorder · metabolic syndrome X
Investigated by
Takeda · National Heart, Lung, and Blood Institute (NHLBI) · EMS · Hospital de Clinicas de Porto Alegre · Yuhan Corporation · VA Office of Research and Development
+38 more · AJU Pharm Co., Ltd. · Creighton University · Hanmi Pharmaceutical Company Limited · Indiana University · National Institute on Aging (NIA) · University of California, San Francisco · Addpharma Inc. · Dialysis Clinic, Inc. · Erasmus Medical Center · Eurofarma Laboratorios S.A. · Farma de Colombia SA · Financiadora de Estudos e Projetos · Hanlim Pharm. Co., Ltd. · Hospital General de México Dr. Eduardo Liceaga · Hospital Israelita Albert Einstein · Icahn School of Medicine at Mount Sinai · Indiana Institute for Medical Research · Instituto de Cardiologia do Rio Grande do Sul · Jessa Hospital · Kyungdong Pharmaceutical Co., Ltd. · Laboratorios Silanes S.A. de C.V. · Libbs Farmacêutica LTDA · Michael E. DeBakey VA Medical Center · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of General Medical Sciences (NIGMS) · National University of Ireland, Galway, Ireland · Parc de Salut Mar · Roche Diagnostics GmbH · Seoul National University Bundang Hospital · University of Alabama at Birmingham · University of Alberta · University of Florida · University of Minnesota · University of Rochester · VA New York Harbor Healthcare System · VA Salt Lake City Health Care System · Virginia Commonwealth University · Vrije Universiteit Brussel

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) HYGROTON — 1960-04-07 fda.gov ↗

Trials 57

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT05077475 Sep 2021 → Apr 2022 hypertensive disorder AJU Pharm Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05077462 Sep 2021 → Apr 2022 hypertensive disorder AJU Pharm Co., Ltd. Unknown No outcome recorded
Phase 1 NCT04757532 Dec 2020 → Mar 2021 — Parc de Salut Mar Completed No outcome recorded
Phase 1 NCT03662620 Oct → Dec 2018 hypertensive disorder Yuhan Corporation Completed No outcome recorded
Phase 1 NCT02152969 May → Aug 2014 hypertensive disorder Yuhan Corporation Completed No outcome recorded
Phase 28 trials · 2 met primary
Phase 2 NCT07645300 Oct 2026 → Mar 2032 expected chronic kidney disease VA Office of Research and Development Not yet recruiting No outcome recorded
Phase 2 NCT05370599 Apr 2022 → Jan 2026 hypertensive disorder University of California, San Francisco Terminated No outcome recorded Stop: Business
Phase 2 NCT05222191 Feb 2022 → Dec 2023 chronic kidney disease, hypertensive disorder Indiana Institute for Medical Research Unknown No outcome recorded
Phase 2 NCT03325114 Jun 2019 → Jun 2020 idiopathic hypercalciuria, type 1 diabetes mellitus University of Rochester Terminated No outcome recorded
Phase 2 NCT03923933 Jun → Oct 2019 chronic kidney disease Hospital General de México Dr. Eduardo Liceaga Completed Met primary
Phase 2 NCT02841280 Jul 2016 → Apr 2021 chronic kidney disease, hypertensive disorder Indiana University Completed Met primary
Phase 2 NCT00000522 Aug 1985 → May 1994 heart disorder, hypertensive disorder University of Minnesota Completed No outcome recorded
Phase 2 NCT00000499 Sep 1980 → May 1983 heart disorder, hypertensive disorder National Heart, Lung, and Blood Institute (NHLBI) Completed No outcome recorded
Phase 328 trials · 10 met primary · 2 missed
Phase 3 NCT06348576 May 2024 → Feb 2025 essential hypertension Addpharma Inc. Unknown Met primary
Phase 3 NCT05920005 Aug 2023 → Mar 2025 hypertensive disorder Hospital Israelita Albert Einstein Completed Met primary
Phase 3 NCT04927299 Jun 2022 → Aug 2023 essential hypertension Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 3 NCT07116863 Jun 2022 → Jun 2024 essential hypertension Kyungdong Pharmaceutical Co., Ltd. Completed Met primary
Phase 3 NCT03928145 Nov 2019 → Jul 2021 essential hypertension Hospital de Clinicas de Porto Alegre Unknown No outcome recorded
Phase 3 NCT02521233 Nov 2016 → May 2017 essential hypertension EMS Withdrawn No outcome recorded Stop: Business
Phase 3 NCT02521246 Nov 2016 → May 2017 essential hypertension EMS Withdrawn No outcome recorded Stop: Business
Phase 3 NCT02620163 Dec 2015 → Dec 2016 essential hypertension Yuhan Corporation Completed No outcome recorded
Phase 3 NCT02916602 Apr 2015 → Sep 2016 hypertensive disorder Hanmi Pharmaceutical Company Limited Completed Met primary
Phase 3 NCT02896621 Dec 2014 → Feb 2016 hypertensive disorder, obstructive sleep apnea syndrome Hospital de Clinicas de Porto Alegre Completed No outcome recorded
Phase 414 trials · 1 met primary · 1 missed
Phase 4 NCT07225764 Oct 2025 → Jun 2027 expected nephrolithiasis, calcium oxalate Icahn School of Medicine at Mount Sinai Recruiting No outcome recorded
Phase 4 NCT06041529 Oct 2023 → Feb 2026 overdue essential hypertension Yuhan Corporation Active not recruiting No outcome recorded
Phase 4 NCT05915286 May 2023 → Feb 2025 end stage renal failure University of Alberta Terminated No outcome recorded
Phase 4 NCT05171686 Feb 2023 → Oct 2025 chronic kidney disease, hypertensive disorder VA Office of Research and Development Completed No outcome recorded
Phase 4 NCT05411991 Jun 2022 → Jul 2024 heart failure Vrije Universiteit Brussel Completed Missed primary
Phase 4 NCT04192110 Aug 2020 chronic kidney disease VA Office of Research and Development Withdrawn No outcome recorded
Phase 4 NCT04330300 Apr 2020 → Jul 2021 COVID-19, essential hypertension National University of Ireland, Galway, Ireland Suspended No outcome recorded Stop: Business
Phase 4 NCT03666351 Oct 2018 → Jul 2022 aortic valve insufficiency, aortic valve stenosis, hypertensive disorder Hanmi Pharmaceutical Company Limited Completed Met primary
Phase 4 NCT03226340 Dec 2015 → Mar 2018 essential hypertension Seoul National University Bundang Hospital Unknown No outcome recorded
Phase 4 NCT02100462 Mar 2014 → Dec 2016 hypertensive disorder Creighton University Unknown No outcome recorded
Phase not applicable2 trials
— NCT02357004 Feb 2015 → Jan 2020 hypertensive disorder University of Alabama at Birmingham Withdrawn No outcome recorded
— NCT02711670 Feb 2014 → Jun 2017 urolithiasis VA New York Harbor Healthcare System Completed No outcome recorded
Comparator or background therapy24 trials
Phase 0 NCT06287580 Comparator Aug 2024 → Feb 2026 essential hypertension University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 1 NCT05090449 Comparator May 2019 → Apr 2020 — Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 1 NCT02496910 Comparator Jun → Sep 2015 hypertensive disorder Yuhan Corporation Completed No outcome recorded
Phase 1 NCT01806363 Comparator Nov 2012 → Jun 2013 hypertensive disorder HanAll BioPharma Co., Ltd. Completed No outcome recorded
Phase 2 NCT07238400 Comparator Mar 2026 → Mar 2029 expected hypertensive disorder Massachusetts General Hospital Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 10

DateIssuerRelease
2025-06-13 Hanmi Pharmaceutical Company Limited Regulatory “고혈압 1차 치료의 새로운 길”…한미약품 ‘아모프렐’ 출격 준비 hanmi.co.kr ↗
한미약품은 최근 식품의약품안전처로부터 저용량 3제 항고혈압제 ‘아모프렐정’의 품목허가를 획득하고 출시를 위한 채비에 들어갔다고 13일 밝혔다.
2024-03-22 Hanmi Pharmaceutical Company Limited Results 한미약품 ‘ 아모잘탄패밀리 ’ 4상 결과, 국제학술지 ‘ AHJ ’ 등재 hanmi.co.kr ↗
이는 Intensive 치료군에서 아모잘탄, 아모잘탄플러스 투여를 통한 우수한 혈압 조절이 좌심실 질량 감소에 유의한 효과를 나타낸다는 것을 입증한 결과다.
2023-11-03 Hanmi Pharmaceutical Company Limited Results “한미 ‘아모잘탄패밀리, 로수젯, 클로잘탄’, 임상적 유용성 뚜렷” hanmi.co.kr ↗
2023-05-04 Hanmi Pharmaceutical Company Limited Regulatory 한미, 저용량 이뇨제 붙인 고혈압 복합제 허가...라인업 지속 확장 hanmi.co.kr ↗
한미약품은 최근 식품의약품안전처로부터 고혈압 치료 복합신약 ‘클로잘탄정 50/6.25mg’을 신규로 허가 받았으며, 오는 7월초 제품을 출시할 예정이라고 밝혔다.
2022-06-02 Hanmi Pharmaceutical Company Limited Regulatory 한미, 고혈압 복합신약 라인업 확대...’클로잘탄’ 허가 획득 hanmi.co.kr ↗
한미약품(대표이사 우종수·권세창)은 최근 식품의약품안전처로부터 ARB 계열 성분 ‘로사르탄(Losartan)’과 Thiazide-like 계열 이뇨제 성분 ‘클로르탈리돈(Chlorthalidone)을 결합한 2제 고혈압 치료 복합제 ‘클로잘탄정’ 2개 용량(50/12.5mg, 100/12.5mg)을 허가 받았다고 2일 밝혔다.
2018-05-23 Hanmi Pharmaceutical Company Limited Results <보도자료> “임상적 효과 입증한 아모잘탄 패밀리, 용량 선택도 다양” hanmi.co.kr ↗
2017-11-07 Hanmi Pharmaceutical Company Limited Results <보도자료> 한미약품, 대한고혈압학회서 ‘아모잘탄 패밀리’ 심포지엄 hanmi.co.kr ↗
2017-10-19 Hanmi Pharmaceutical Company Limited Results <보도자료> 한미약품 ‘아모잘탄플러스’ 3상 결과, SCI급 국제학술지 등재 hanmi.co.kr ↗
임상 결과, 아모잘탄플러스 투여군이 Amlodipine/Losartan 2제 요법 투여군과 비교하여 기저치 대비 8주 후 sitSBP를 평균 9.5mmHg 더 감소시키는 결과를 보였다.
2017-10-13 Hanmi Pharmaceutical Company Limited Results <보도자료> 한미약품, 대한심장학회서 ‘아모잘탄 패밀리’ 심포지엄 열어 hanmi.co.kr ↗
2017-06-30 Hanmi Pharmaceutical Company Limited Regulatory <보도자료> 한미, 고혈압치료 3제 복합신약 ‘아모잘탄플러스’ 허가 hanmi.co.kr ↗
한미약품(대표이사 우종수·권세창, www.hanmi.co.kr)은 지난 29일 고혈압치료 3제 복합신약인 ‘아모잘탄플러스’의 시판허가를 식품의약품안전처로부터 받았다고 30일 밝혔다.

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 84 sources stand behind the page.

FieldValueCited text
Known as chlorthalidone “The participant's blood pressure medication regimen will then be altered to initiate a thiazide-type (hydrochlorothiazide or chlorthalidone) or loop diuretic (furosemide,...” NCT04192110 ↗
80

“Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together” NCT05077462 ↗

“Fixed-dose combination tablet containing valsartan 160 mg, amlodipine 10 mg, and chlorthalidone 25 mg.” NCT07116863 ↗

“Hydrochlorothiazide, metolazone, chlorthalidone, chlorothiazide, bendroflumethiazide, indapamide” NCT04330300 ↗

“renin guided therapeutics-chlorothiazide, chlorthalidone, hydrochlorothiazide” NCT00684489 ↗

“Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning” NCT01896661 ↗

“telmisartan/amlodipine/chlorthalidone 20/2.5/6.25 mg” PMID 41717679 ↗ Feb 2026

“telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg” NCT02620163 ↗

“amlodipine, Losartan, Chlorthalidone FDC” NCT02916602 ↗

“C52R2(Chlorthalidone) 25 mg tablet” NCT05077475 ↗

“chlorthalidone (Thalitone)” NCT00000620 ↗

Show 70 more sources

Known as chlorthalidone (Thalitone) “chlorthalidone (Thalitone)” NCT00000620 ↗
Known as CTD “We performed 12-hour urine collections in 7 patients taking 25 mg of chlorthalidone (CTD) and 10 patients taking 25 mg of hydrochlorothiazide (HCTZ).” PMID 40194294 ↗ Apr 2025
4

“chlorthalidone (CTD) is a thiazide-like diuretic used for treating hypertension and decreases serum K.” NCT05222191 ↗

“Chlorthalidone (CTD) is a thiazide-like diuretic and an effective antihypertensive drug” PMID 32663820 ↗ Jul 2020

“Chlorthalidone (CTD) may be superior to hydrochlorothiazide (HCTZ)” PMID 36067089 ↗ Sep 2022

“Chlorthalidone (CTD)” NCT02185417 ↗

Known as HIGROTON 50 “Chlorthalidone (HIGROTON® 50)” NCT05090449 ↗
Known as Hygroton (brand name for chlorthalidone) “Hygroton (brand name for chlorthalidone)” NCT05411991 ↗
Modality Other / unclassified “Chlorthalidone is a thiazide-like diuretic” NCT00591773 ↗
Route Oral “chlorthalidone 25 mg, tablets, orally, once daily” NCT00591773 ↗