Clinical Trials

Enalapril maleate has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 to assess its efficacy in managing hypertension, heart failure with reduced ejection fraction, macroalbuminuric diabetic nephropathy, morbid obesity, and oncology-related cardioprotection. These studies are sponsored by a broad array of entities, including academic institutions, NHS trusts, private research organizations, and pharmaceutical companies. Across the portfolio, trial statuses range from actively recruiting and non-recruiting to completed and terminated protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07363343 RECRUITING
Hypertension; Postpartum Preeclampsia
The Cleveland Clinic
 2026-03-10
NCT06788314 RECRUITING
Venous Malformation; Pain; Quality of Life; Vascular Malformation
Oslo University Hospital
 2025-02-01 PHASE2
NCT04183101 RECRUITING
C3 Glomerulopathy; Membranoproliferative Glomerulonephritis; Complement Abnormality; Dense Deposit Disease; C3 Glomerulonephritis
Region Skane
 2020-10-01 PHASE2
NCT07547878 NOT_YET_RECRUITING
Chronic Kidney Disease; Type 2 Diabetes
Baylor Research Institute
 2026-04-30 PHASE4
NCT07023003 RECRUITING
Hypertension in Pregnancy
Nebraska Methodist Health System
 2025-07-11 PHASE4
NCT07568574 ENROLLING_BY_INVITATION
Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes
Enhanced Emirates Limited
 2026-03-12
NCT07222852 RECRUITING
Preeclampsia; Hypertensive Disorder of Pregnancy; Hypertension; Gestational Hypertension; Gestational Hypertension After Childbirth
Women and Infants Hospital of Rhode Island
 2026-01-01 PHASE3
NCT05259137 WITHDRAWN
Hypertrophic Scar
Nova Scotia Health Authority
 2024-08 PHASE2; PHASE3
NCT03051282 COMPLETED
Healthy Volunteers
University of Michigan
 2017-04-01 PHASE4
NCT04023227 COMPLETED
Chagas Disease; Heart Failure
Novartis Pharmaceuticals
 2019-12-10 PHASE4
NCT05487261 UNKNOWN
Heart Failure
Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań
 2022-12-13 PHASE4
NCT06187493 UNKNOWN
Diabetic Kidney Disease
Assiut University
 2024-01-01
NCT04853758 UNKNOWN
Chagas Cardiomyopathy
University of Sao Paulo General Hospital
 2021-05-06 PHASE3
NCT05271448 UNKNOWN
Contrast-induced Nephropathy; Chronic Kidney Diseases; Ischemic Heart Disease
An-Najah National University
 2021-06-01
NCT05373004 UNKNOWN
Diabetic Nephropathy Type 2
Omar Tarek Elfarargi
 2023-03 PHASE2; PHASE3
NCT03265574 COMPLETED
Breast Cancer; Non Hodgkin Lymphoma
South Tees Hospitals NHS Foundation Trust
 2017-10-04 PHASE3
NCT04484350 COMPLETED
Stroke, Acute; Vessels; Occlusion; Blood Pressure; Endovascular Thrombectomy; Mechanical Thrombectomy
Hamilton Health Sciences Corporation
 2020-10-23 PHASE2
NCT05711810 COMPLETED
Severe Acute Respiratory Syndrome-related Coronavirus; Renal Dialysis; Vaccines; Myocarditis Allergic; Infection Viral
Yang I. Pachankis
 2023-01-02 PHASE4
NCT03179163 TERMINATED
Hypertension,Essential
Penn State University
 2016-07-20 PHASE1; PHASE2
NCT04736329 COMPLETED
Heart Failure With Reduced Ejection Fraction; Renal Insufficiency
Cairo University
 2021-02-01
NCT04912167 UNKNOWN
STEMI
West China Hospital
 2021-11 PHASE3
NCT05232370 COMPLETED
Oxidative Stress
Unidad de Investigacion Medica en Enfermedades Renales
 2022-01-01 PHASE2
NCT02678312 COMPLETED
Pediatric Heart Failure
Novartis Pharmaceuticals
 2016-11-03 PHASE2; PHASE3
NCT04640571 COMPLETED
Bile Salt Export Pump (BSEP) Transporter; Polysorbate 80
University of Maryland, Baltimore
 2021-04-01 PHASE4
NCT02281838 TERMINATED
Intracerebral Hemorrhage
University of Alberta
 2011-08-01 PHASE2
NCT04236258 COMPLETED
Hypertension in Pregnancy; Preeclampsia Severe; Gestational Hypertension; Postpartum Preeclampsia; Postpartum
Brigham and Women's Hospital
 2020-01-24 PHASE4
NCT03917459 COMPLETED
Heart Failure; Heart Failure, Systolic; Erectile Dysfunction
Novartis Pharmaceuticals
 2019-04-16 PHASE3
NCT04736329 Completed
Heart Failure With Reduced Ejection Fraction|Renal Insufficiency
Cairo University
 2021-02-01 Not Applicable
NCT03190304 COMPLETED
Heart Failure; Exercise Tolerance; Vasodilation; Body Composition; Muscle Strength
University of Sao Paulo General Hospital
 2017-06-14 PHASE4
NCT03466333 COMPLETED
Cardiovascular Diseases; Pre-Eclampsia Onset Less Than 37 Weeks (Diagnosis)
Manchester University NHS Foundation Trust
 2018-09-05 PHASE2
NCT01007994 COMPLETED
Hypertension Secondary to Kidney Transplant
Northwell Health
 2009-11 PHASE2; PHASE3
NCT03005184 WITHDRAWN
Heart Failure NYHA Class I; Heart Failure NYHA Class II; Heart Failure NYHA Class III
Vanderbilt University Medical Center
 2017-09 PHASE2
NCT03949075 COMPLETED
Exercise; Angiotensin-Converting Enzyme Inhibitors
University of Copenhagen
 2019-05-15
NCT01968200 UNKNOWN
Cancer
European Institute of Oncology
 2012-12 PHASE3
NCT02768298 COMPLETED
Chronic Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-07-12 PHASE4
NCT03066804 COMPLETED
Heart Failure With Preserved Ejection Fraction
Novartis Pharmaceuticals
 2017-08-22 PHASE3
NCT03119623 WITHDRAWN
Heart Failure With Reduced Ejection Fraction
Brigham and Women's Hospital
 2017-06-01 PHASE4
NCT04952051 COMPLETED
Hypertension
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2014-07-01 PHASE3
NCT03526042 UNKNOWN
Atherosclerosis; Lupus Nephritis
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2017-09-10
NCT03472508 UNKNOWN
Hypertension
Shenzhen Ausa Pharmed Co.,Ltd
 2018-03-20 PHASE4
NCT02575092 COMPLETED
Homocysteine; Coronary Disease; Angioplasty,Balloon,Coronary; Contrast Media; Nephropathy; Hypertension
Fuling Central Hospital of Chongqing City
 2015-11-01 PHASE2; PHASE3
NCT02468232 COMPLETED
Heart Failure With Reduced Ejection Fraction (HF-rEF)
Novartis Pharmaceuticals
 2015-06-15 PHASE3
NCT02874794 COMPLETED
Heart Failure and Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-08-17 PHASE4
NCT02554890 COMPLETED
Acute Heart Failure
Novartis Pharmaceuticals
 2016-04-29 PHASE4
NCT02900378 COMPLETED
Chronic Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-12-20 PHASE3
NCT01754909 COMPLETED
Lung Cancer; Radiation Pneumonitis
VA Office of Research and Development
 2013-11-01 PHASE2
NCT02654678 UNKNOWN
Heart Failure; Dilated Cardiomyopathy; Congenital Heart Disease
Ethicare GmbH
 2016-03 PHASE2; PHASE3
NCT02623036 UNKNOWN
Hypertension, Resistant to Conventional Therapy
Memorial Health University Medical Center
 2015-11 PHASE1
NCT02970669 COMPLETED
Heart Failure, Reduced Ejection Fraction
Novartis Pharmaceuticals
 2016-12-16 PHASE4
NCT03667131 COMPLETED
Rheumatoid Arthritis
University of Guadalajara
 2017-02-13 PHASE2
NCT03265574 Completed
Breast Cancer|Non Hodgkin Lymphoma
South Tees Hospitals NHS Foundation Trust|Newcastle University|University of Durham|Newcastle-upon-Tyne Hospitals NHS Trust
 2017-10-04 Phase 3
NCT02639637 COMPLETED
Type 2 Diabetes Mellitus
Vanderbilt University
 2015-12 PHASE4
NCT02652728 UNKNOWN
Heart Failure; Dilated Cardiomyopathy
Ethicare GmbH
 2016-01 PHASE2; PHASE3
NCT02652741 UNKNOWN
Heart Failure; Congenital Heart Disease
Ethicare GmbH
 2016-01 PHASE2; PHASE3
NCT02214498 UNKNOWN
Essential Hypertension
Erasmus Medical Center
 2015-05 PHASE4
NCT03051282 Active not recruiting
Healthy Volunteers
University of Michigan
 2017-04-01 Phase 4
NCT01705392 TERMINATED
Metastatic Malignant Melanoma; Unresectable Malignant Melanoma
Haukeland University Hospital
 2013-01 PHASE2
NCT03460366 Recruiting
Obesity Morbid
Norwegian University of Science and Technology|St. Olavs Hospital|Volvat Medisinsk Senter Stokkan|Namsos Hospital|Alesund Hospital
 2016-11-02 --
NCT01364675 UNKNOWN
Pre-diabetes; Pre-hypertension
Ramathibodi Hospital
 2012-01
NCT02654678 Unknown status
Heart Failure|Dilated Cardiomyopathy|Congenital Heart Disease
Ethicare GmbH
 2016-03 Phase 2|Phase 3
NCT00853658 COMPLETED
Chronic Heart Failure
Novartis Pharmaceuticals
 2009-03 PHASE3
NCT01151410 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2010-08 PHASE3
NCT02252692 UNKNOWN
Heart Failure
Ethicare GmbH
 2014-08 PHASE1
NCT01891292 UNKNOWN
Microalbuminuria; Sickle Cell Nephropathy
The University of The West Indies
 2013-07
NCT01437371 COMPLETED
Heart Failure
University Hospital, Clermont-Ferrand
 2011-08 PHASE3
NCT01871740 WITHDRAWN
Hypertension; Hyperhomocysteinemia
Shenzhen Ausa Pharmed Co.,Ltd
 2008-05 PHASE4
NCT02135263 COMPLETED
Carboxylesterase 1 (CES1) Genotype; CES1 Activity
Bispebjerg Hospital
 2012-04 PHASE4
NCT01035255 TERMINATED
Heart Failure With Reduced Ejection Fraction
Novartis Pharmaceuticals
 2009-12 PHASE3
NCT00895414 COMPLETED
Breast Cancer
Masonic Cancer Center, University of Minnesota
 2009-04
NCT00794885 COMPLETED
Primary Hypertension
Shenzhen Ausa Pharmed Co.,Ltd
 2008-05 PHASE4
NCT01413542 COMPLETED
Hypertension; Diabetes Type 2
Vanderbilt University
 2011-11
NCT01822639 COMPLETED
Hypertension
GlaxoSmithKline
 2013-04-03 PHASE1
NCT02879721 COMPLETED
Barrett's Esophagus
Göteborg University
 2009-10 EARLY_PHASE1
NCT01624064 UNKNOWN
Renal Insufficiency, Chronic
Ministry of Health, Sri Lanka
 2012-08 PHASE1; PHASE2
NCT02432885 COMPLETED
Myocardial Fibrosis; Muscular Dystrophies
InCor Heart Institute
 2009-06 PHASE3
NCT01667614 COMPLETED
Type 2 Diabetes Mellitus; Diabetic Nephropathy; Essential Hypertension
Tehran University of Medical Sciences
 2010-05 PHASE2
NCT01096121 TERMINATED
Sickle Cell Disease
Assistance Publique - Hôpitaux de Paris
 2010-06
NCT01110824 COMPLETED
Acute Myeloid Leukemia; Precursor-cell Lymphoblastic Leukemia-Lymphoma; Lymphoid Neoplasm; Multiple Myeloma; Lymphoma; Autologous Hematopoietic Stem Cell Transplantation
Hospital Clinic of Barcelona
 2008-04 PHASE3
NCT01211314 TERMINATED
Hypertension
Meir Medical Center
 2011-01 PHASE4
NCT00963976 COMPLETED
Intracerebral Hemorrhage
University of Alberta
 2007-01 PHASE2
NCT00292526 COMPLETED
Cardiotoxicity; Chemotherapeutic Toxicity
European Institute of Oncology
 2000-11 PHASE4
NCT01305850 UNKNOWN
Peritoneal Membrane Failure
Chulalongkorn University
 2010-07 PHASE4
NCT01093807 COMPLETED
Essential Hypertension
RECORDATI GROUP
 2010-03 PHASE2
NCT01069042 UNKNOWN
Heart Failure
National Cheng-Kung University Hospital
 2010-02 PHASE4
NCT01041963 UNKNOWN
Continuous Ambulatory Peritoneal Dialysis
Chulalongkorn University
 2009-06 PHASE4
NCT01117038 COMPLETED
Erectile Dysfunction
VIVUS LLC
 2010-04 PHASE1
NCT01115946 COMPLETED
Healthy; Pharmacokinetics of Enalapril
Astellas Pharma Inc
 2010-03 PHASE1
NCT00456963 TERMINATED
Diabetes Mellitus; Hypertension
Istituto Auxologico Italiano
 2007-09 PHASE4
NCT00741156 COMPLETED
Hypertension; Congestive Cardiomyopathy
The Hospital for Sick Children
 2008-07 PHASE3
NCT00270153 COMPLETED
Renal Transplant
Montefiore Medical Center
 2004-09 PHASE1
NCT00666848 COMPLETED
Metabolic Syndrome; Hypertension
Vanderbilt University
 2008-03 PHASE4
NCT00292162 COMPLETED
Chronic Heart Failure; Atrial Fibrillation
NHS Greater Glasgow and Clyde
 2007-01
NCT01061450 COMPLETED
Diastolic Dysfunction; Hypertension
Brasilia Heart Study Group
 2006-11 PHASE4
NCT00446511 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2007-06 PHASE3
NCT00248807 COMPLETED
Orthostatic Hypotension; Spinal Cord Injuries
VA Office of Research and Development
 2005-10
NCT00734123 UNKNOWN
Atherosclerosis; Cardiovascular Diseases
Hospital Arnau de Vilanova
 2008-04 PHASE4
NCT00295542 COMPLETED
Hypertension
University of Vigo
 2000-03 PHASE4
NCT00433836 COMPLETED
Hypertension
Novartis Pharmaceuticals
 2007-01 PHASE3
NCT00391846 COMPLETED
Heart Failure; Ventricular Dysfunction, Left
AstraZeneca
 2006-10 PHASE4
NCT00568178 COMPLETED
Proteinuria
Organon and Co
 2007-06-01 PHASE3
NCT00113087 COMPLETED
Heart Defects, Congenital; Heart Failure, Congestive
National Heart, Lung, and Blood Institute (NHLBI)
 2003-08 PHASE3
NCT00543413 COMPLETED
Hypertension
Merck Sharp & Dohme LLC
 2007-10 PHASE2
NCT00419835 COMPLETED
Macroalbuminuric Diabetic Nephropathy
University of Sao Paulo
 2005-05 PHASE4
NCT00226096 COMPLETED
CVA (Cerebrovascular Accident); Cerebral Hemorrhage; Intracranial Hemorrhages
The George Institute
 2005-11
NCT00296218 COMPLETED
Myocardial Ischemia; Hypertension
Sanofi
 2006-02 PHASE3
NCT00302705 COMPLETED
Hypertension
University of Vigo
 2005-01 PHASE4
NCT00143949 COMPLETED
Type 1 Diabetes
Michael Mauer, MD
 1997-03 PHASE2
NCT00113698 TERMINATED
Heart Defects, Congenital; Heart Septal Defects, Ventricular; Heart Failure, Congestive
University of Utah
 2004-12 PHASE3
NCT01411735 COMPLETED
Heart Failure With Preserved Ejection Fraction; Heart Failure, Congestive
Wake Forest University
 2003-07 PHASE3
NCT00274118 COMPLETED
Hypertension; Diabetes Mellitus, Type 2
Boehringer Ingelheim
 1997-07 PHASE3
NCT00367978 COMPLETED
Hypertension
Novartis
 2001-12 PHASE4
NCT00003070 COMPLETED
Cardiac Toxicity; Unspecified Childhood Solid Tumor, Protocol Specific
Children's Oncology Group
 2000-09 PHASE3
NCT02177461 COMPLETED
Hypertension
Boehringer Ingelheim
 2000-04 PHASE4
NCT00151619 TERMINATED
Chronic Heart Failure
Rennes University Hospital
 1999-02-10 PHASE2
NCT02177448 COMPLETED
Hypertension
Boehringer Ingelheim
 1998-09 PHASE3
NCT00882440 COMPLETED
Hypertension
Merck Sharp & Dohme LLC
 1990-12 PHASE3
NCT00000522 COMPLETED
Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
University of Minnesota
 1985-08 PHASE2
NCT00427271 UNKNOWN
Diabetes Mellitus; Microalbuminuria
Hospital de Clinicas de Porto Alegre
 2003-03 PHASE4
NCT00004328 COMPLETED
Pseudohypoaldosteronism
National Center for Research Resources (NCRR)
 1992-12 PHASE2
NCT00000516 COMPLETED
Cardiovascular Diseases; Coronary Disease; Heart Diseases; Heart Failure; Hypertension; Myocardial Ischemia
National Heart, Lung, and Blood Institute (NHLBI)
 1985-07 PHASE3
NCT00141583 TERMINATED
Hypertension
St George's, University of London
 2004-04
NCT00484068 COMPLETED
Microalbuminuria; Diabetic Nephropathy
Hospital de Clinicas de Porto Alegre
 2003-01
NCT00000547 COMPLETED
Cardiovascular Diseases; Heart Diseases; Heart Failure; Myocardial Diseases
National Heart, Lung, and Blood Institute (NHLBI)
 1994-04 PHASE3
NCT00520247 COMPLETED
Plasma Total Homocysteine Level; Blood Pressure
Anhui Medical University
 2005-09 PHASE2
NCT00006137 COMPLETED
IGA Glomerulonephritis
National Center for Research Resources (NCRR)
 2000-05
NCT00235287 UNKNOWN
Kidney Failure, Chronic; Cardiovascular Diseases
Herlev Hospital
 2005-09 PHASE4
NCT00899587 UNKNOWN
Diabetic Macular Ischemia
Shahid Beheshti University of Medical Sciences
 PHASE1
NCT00394394 COMPLETED
Hypertension
Hospital de Clinicas de Porto Alegre
 2005-02 PHASE2
NCT00367562 COMPLETED
IGA Nephropathy
Hospital Britanico
 1996-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enalapril maleate acts as a prodrug whose active form competitively binds to angiotensin-converting enzyme (ACE), inhibiting the conversion of angiotensin I to the potent vasoconstrictor angiotensin II while reducing kininase II-mediated degradation of vasodilator bradykinin. This enzyme inhibition diminishes systemic vascular resistance, decreases aldosterone secretion, and promotes vasodilation, thereby mitigating elevated blood pressure and providing cardioprotective and renoprotective effects in clinical contexts such as hypertension, heart failure, and diabetic nephropathy.

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>).

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