Clinical Trials

Numerous clinical trials evaluate captopril across cardiovascular, metabolic, and respiratory indications—including hypertension, heart failure, left ventricular dysfunction, chronic kidney disease, type 2 diabetes, aortic aneurysms, and COVID-19-related pneumonia—alongside pharmacokinetic studies in healthy volunteers. Ranging from early Phase 1 to Phase 4, these protocols are sponsored by industry leaders like GlaxoSmithKline and AstraZeneca as well as academic institutions such as Brigham and Women's Hospital and Assistance Publique - Hôpitaux de Paris. The overall clinical landscape encompasses completed, active, recruiting, withdrawn, and terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06190158 ACTIVE_NOT_RECRUITING
Type 2 Diabetes; Chronic Kidney Diseases
Brigham and Women's Hospital
 2024-05-15 EARLY_PHASE1
NCT07272486 COMPLETED
Hypertensive Urgency; Primary Hypertension
Ankara City Hospital Bilkent
 2024-08-01
NCT06141200 UNKNOWN
Essential Hypertension
Natural Wellness Egypt
 2024-03 PHASE3
NCT04893629 TERMINATED
Cardiomyopathy
Damascus University
 2021-05-20
NCT04629651 WITHDRAWN
Bone Marrow Fibrosis; Myeloproliferative Neoplasm
Case Comprehensive Cancer Center
 2024-04 PHASE1; PHASE2
NCT06485661 UNKNOWN
Effect of Drug
Ain Shams University
 2024-01-01 EARLY_PHASE1
NCT06292091 COMPLETED
Hypertension
Seoul National University Hospital
 2024-02-28 PHASE1
NCT06253429 UNKNOWN
Type 1 Diabetes
Ain Shams University
 2023-01-01 PHASE3
NCT04224675 UNKNOWN
Aneurysm
Onassis Cardiac Surgery Centre
 2020-03-07
NCT03179163 TERMINATED
Hypertension,Essential
Penn State University
 2016-07-20 PHASE1; PHASE2
NCT03613506 UNKNOWN
Radiotherapy Side Effect; Taking Captopril
Wuhan University
 2019-10-25 PHASE2
NCT04964050 WITHDRAWN
Healthy Volunteers
GlaxoSmithKline
 2022-04-21 PHASE1
NCT04964050 Withdrawn
Healthy Volunteers
GlaxoSmithKline
 2022-04-21 Phase 1
NCT04878315 WITHDRAWN
Healthy Volunteers
GlaxoSmithKline
 2022-02-13 PHASE1
NCT04878315 Withdrawn
Healthy Volunteers
GlaxoSmithKline
 2022-02-13 Phase 1
NCT05826080 Recruiting
Primary Aldosteronism|Aldosterone-Producing Adenoma|Idiopathic Hyperaldosteronism
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2021-09-01 --
NCT04288700 UNKNOWN
Infantile Hemangioma
Ain Shams University
 2019-10-01 PHASE4
NCT04578236 UNKNOWN
Covid19
Kafrelsheikh University
 2020-11 PHASE2
NCT01626469 UNKNOWN
Type 2 Diabetes Mellitus
Brigham and Women's Hospital
 2012-05 PHASE1; PHASE2
NCT04485845 UNKNOWN
Metabolic Syndrome; Diabete Type 2; Kidney Insufficiency
Cairo University
 2019-11-01 PHASE4
NCT04355429 UNKNOWN
Pneumonia; Coronavirus Infection; COVID-19
Assistance Publique - Hôpitaux de Paris
 2020-05-05 PHASE2
NCT03147092 UNKNOWN
Hypertension; Blood Pressure
Centro Neurológico de Pesquisa e Reabiitação, Brazil
 2018-02-01 EARLY_PHASE1
NCT04355429 Unknown status
Pneumonia|Coronavirus Infection|COVID-19
Assistance Publique - Hôpitaux de Paris
 2020-05-05 Phase 2
NCT04224675 Unknown status
Aneurysm
Onassis Cardiac Surgery Centre
 2020-03-07 Not Applicable
NCT03660293 COMPLETED
Diabetes Mellitus, Type 1
Tanta University
 2017-04-01
NCT02770378 COMPLETED
Glioblastoma
University of Ulm
 2016-11 PHASE1; PHASE2
NCT04371874 COMPLETED
Hypertension
First Affiliated Hospital Xi'an Jiaotong University
 2014-01
NCT01292694 TERMINATED
Hypertension; Pure Autonomic Failure; Multiple System Atrophy
Vanderbilt University
 2011-03 PHASE1
NCT00223717 COMPLETED
Hypertension
Vanderbilt University
 2001-01 PHASE1
NCT02217852 UNKNOWN
Hypertension
West China Hospital
 2014-08 PHASE4
NCT01437371 COMPLETED
Heart Failure
University Hospital, Clermont-Ferrand
 2011-08 PHASE3
NCT01761916 COMPLETED
Preeclampsia
Instituto Materno Infantil Prof. Fernando Figueira
 2013-01 PHASE4
NCT01271478 COMPLETED
Inflammation; End-stage Renal Disease
Coordinación de Investigación en Salud, Mexico
 2009-08 PHASE4
NCT01545479 COMPLETED
Renal Disease
Instituto de Cardiologia do Rio Grande do Sul
 2010-01 PHASE4
NCT00660309 COMPLETED
Type 2 Diabetes Mellitus
Novartis
 2008-04 PHASE4
NCT00742040 UNKNOWN
Heart Disease
The Hospital for Sick Children
 2008-08 PHASE2
NCT00292162 COMPLETED
Chronic Heart Failure; Atrial Fibrillation
NHS Greater Glasgow and Clyde
 2007-01
NCT00391846 COMPLETED
Heart Failure; Ventricular Dysfunction, Left
AstraZeneca
 2006-10 PHASE4
NCT00077064 TERMINATED
Lung Cancer; Pulmonary Complications; Radiation Fibrosis
Radiation Therapy Oncology Group
 2003-06 PHASE2
NCT00663949 COMPLETED
Diabetic Nephropathy
Shiraz University of Medical Sciences
 2006-02 PHASE2; PHASE3
NCT00518765 COMPLETED
Hypertension
Novartis
 2005-10 PHASE3
NCT00086723 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Northwestern University
 2003-07 PHASE1; PHASE2
NCT00155064 COMPLETED
Hyperaldosteronism
National Taiwan University Hospital
 2002-07 PHASE4
NCT00004230 COMPLETED
Cancer
Northwestern University
 1999-10 PHASE3
NCT00252317 UNKNOWN
Aortic Stenosis
Rigshospitalet, Denmark
 2005-11 PHASE4
NCT00240656 COMPLETED
Hypertension, Pulmonary
Hebei Medical University
 2005-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-13)

Check the Captopril product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Captopril acts as a potent inhibitor of angiotensin-converting enzyme (ACE) with an IC50 of 6 nM, binding to the enzyme's active site to prevent the conversion of angiotensin I to the vasoconstrictor angiotensin II while reducing degradation of the vasodilator bradykinin. This enzymatic block decreases systemic vascular resistance and attenuates aldosterone secretion, providing the clinical rationale for its investigation and therapeutic utility in managing hypertension, heart failure, and chronic kidney disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.