Clinical Trials

Atenolol has been evaluated across numerous clinical trials for cardiovascular and vascular conditions, including essential hypertension, atrial fibrillation, thoracic aortic aneurysm, Marfan syndrome, stable angina pectoris, ischemic stroke, and spinal hemangioma. These studies span Early Phase 1 through Phase 4 protocols and unassigned categories, with recruitment statuses ranging from actively recruiting and completed to terminated, withdrawn, or unknown. Research sponsors encompass academic medical centers, such as Vanderbilt University Medical Center and the Onassis Cardiac Surgery Centre, alongside pharmaceutical companies like Daiichi Sankyo.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07268170 ENROLLING_BY_INVITATION
Coronary Arterial Disease (CAD); Ischemic Heart Disease (IHD)
Gødstrup Hospital
2025-12-15 PHASE2; PHASE3
NCT02560805 RECRUITING
Stress Disorders, Post-Traumatic
Emory University
2015-10 PHASE2
NCT04905277 COMPLETED
Healthy
Sundeep Khosla, M.D.
2021-07-27 PHASE2
NCT04914234 RECRUITING
Hypotension Drug-Induced
Damanhour Teaching Hospital
2025-08-01 PHASE4
NCT06505668 UNKNOWN
Treatment Resistant Schizophrenia; Clozapine Adverse Reaction; Heart Rate Variability; Tachycardia
All India Institute of Medical Sciences, Bhubaneswar
2023-08-01
NCT06670690 COMPLETED
Intraoperative Bleeding
Menoufia University
2023-09-01
NCT04931108 UNKNOWN
Hypertension
Shanghai Jiao Tong University School of Medicine
2021-09-27 PHASE4
NCT04224675 UNKNOWN
Aneurysm
Onassis Cardiac Surgery Centre
2020-03-07
NCT03578354 WITHDRAWN
Vestibular Migraine; Migraine Disorders; Vestibular Diseases
Massachusetts Eye and Ear Infirmary
2019-01 PHASE2
NCT05106179 UNKNOWN
Spinal Tumor; Spinal Hemangioma; Beta Blocker Toxicity
Center for Vascular Pathology, Moscow
2021-12 PHASE4
NCT03082014 TERMINATED
Cerebral Small Vessel Diseases
Ludwig-Maximilians - University of Munich
2018-02-22 PHASE3
NCT04513509 COMPLETED
Atrial Fibrillation; Rate Control; Cardiopulmonary Exercise Test
National Taiwan University Hospital
2020-10-21
NCT03147092 UNKNOWN
Hypertension; Blood Pressure
Centro Neurológico de Pesquisa e Reabiitação, Brazil
2018-02-01 EARLY_PHASE1
NCT04224675 Unknown status
Aneurysm
Onassis Cardiac Surgery Centre
2020-03-07 Not Applicable
NCT03245970 WITHDRAWN
Chronic Hypertension Complicating Pregnancy (Diagnosis); Preeclampsia
University of Tennessee Medical Center
2017-04-24 EARLY_PHASE1
NCT03105661 UNKNOWN
Obesity, Morbid; Preeclampsia
University of Tennessee Graduate School of Medicine
2017-04-04 EARLY_PHASE1
NCT01009944 WITHDRAWN
Hypertension
Brigham and Women's Hospital
2007-01
NCT03237637 UNKNOWN
Infantile Hemangioma
Post Graduate Institute of Medical Education and Research, Chandigarh
2017-03-24 PHASE3
NCT02342275 COMPLETED
Hemangioma
West China Hospital
2013-10 PHASE3
NCT02467400 COMPLETED
Osteoporosis, Age-Related
Mayo Clinic
2015-07-01 EARLY_PHASE1
NCT02623569 UNKNOWN
Angina Pectoris
Xintong Pharmacy Company
2014-10 PHASE2
NCT01904981 COMPLETED
Small Abdominal Aortic Aneurysm
Yonsei University
2014-01 PHASE4
NCT01522950 COMPLETED
Hypertension
University of Minnesota
2010-05 PHASE2
NCT01719367 COMPLETED
Atrial Fibrillation
Vanderbilt University Medical Center
2013-01
NCT03245996 COMPLETED
Aortic Blood Pressure
Tartu University Hospital
2015-06 PHASE4
NCT01736488 COMPLETED
Hypertension
Boryung Pharmaceutical Co., Ltd
2012-10 PHASE4
NCT02479204 TERMINATED
Healthy Subjects
Viatris Innovation GmbH
2015-04-28 PHASE1
NCT01202721 TERMINATED
Cardiac Disease
Hamilton Health Sciences Corporation
2011-06 PHASE3
NCT02403349 UNKNOWN
Blood Pressure; Ischemic Stroke
Ajou University School of Medicine
2012-05 PHASE4
NCT01715207 COMPLETED
Marfan Syndrome
Samsung Medical Center
2010-06 PHASE3
NCT01939509 COMPLETED
Hypertension; Metabolic Syndrome
Hospital Italiano de Buenos Aires
2012-02 PHASE4
NCT01795235 UNKNOWN
Healthy
University of Virginia
2012-12
NCT00625742 TERMINATED
Advanced Cancer; Cachexia
M.D. Anderson Cancer Center
2008-02
NCT01839253 COMPLETED
Orthognathic Surgery
Yonsei University
2012-08
NCT00429364 COMPLETED
Marfan Syndrome
Carelon Research
2007-01 PHASE3
NCT01230892 COMPLETED
Atherosclerosis; Endothelial Function
Emory University
2010-02 PHASE4
NCT00582114 TERMINATED
Hemodialysis; Hypertension; Left Ventricular Hypertrophy
Indiana University
2005-08 PHASE3
NCT02547597 COMPLETED
Stable Angina Pectoris
Gachon University Gil Medical Center
2011-04 PHASE4
NCT00925119 TERMINATED
Diabetes Mellitus, Type 2
University of Maryland, Baltimore
2009-12 PHASE4
NCT01145612 UNKNOWN
Marfan Syndrome
Forteza, Albert, M.D.
2008-10 PHASE3
NCT01719367 Completed
Atrial Fibrillation
Vanderbilt University Medical Center
2013-01 Not Applicable
NCT00837902 COMPLETED
Healthy
Vanderbilt University
2009-01
NCT03070730 TERMINATED
Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance
Beth Israel Deaconess Medical Center
2011-08-15 PHASE1; PHASE2
NCT00723801 COMPLETED
Marfan Syndrome
Brigham and Women's Hospital
2007-10 PHASE3
NCT01251146 COMPLETED
Hypertension
Merck KGaA, Darmstadt, Germany
2010-11 PHASE4
NCT01762436 COMPLETED
Untreated Essential Hypertension
Ruijin Hospital
2010-11 PHASE4
NCT01397994 UNKNOWN
Chronic Stable Angina
Ferozsons Laboratories Ltd.
2011-09 PHASE4
NCT00535925 COMPLETED
Diabetic Nephropathy
University of Campania Luigi Vanvitelli
2005-10 PHASE4
NCT01445964 COMPLETED
Healthy
Seoul National University Hospital
2011-05 PHASE4
NCT01079962 COMPLETED
Hypertension
Merck KGaA, Darmstadt, Germany
2009-12 PHASE4
NCT01132768 TERMINATED
Essential Hypertension; Carotid Plaque
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
2010-05 PHASE4
NCT01361087 Withdrawn
Marfan Syndrome
Ann & Robert H Lurie Children''s Hospital of Chicago|Johns Hopkins University
2011-04 Phase 3
NCT00651235 UNKNOWN
Marfan Syndrome
National Taiwan University Hospital
2007-02 PHASE2
NCT00246519 COMPLETED
Hypertension
University of Florida
2005-10 PHASE4
NCT00593710 COMPLETED
Marfan Syndrome
University of British Columbia
2008-01 PHASE2
NCT01022463 COMPLETED
Mitral Stenosis
Govind Ballabh Pant Hospital
2009-11 PHASE3
NCT00669279 COMPLETED
Hypertension
University of Florida
2008-04 PHASE4
NCT01132768 Terminated
Essential Hypertension|Carotid Plaque
Daiichi Sankyo Europe GmbH a Daiichi Sankyo Company|Daiichi Sankyo
2010-05 Phase 4
NCT00661895 COMPLETED
Hypertension
Creighton University
2005-08 PHASE4
NCT00607347 COMPLETED
Hypertension
University of Florida
2008-02
NCT01030016 COMPLETED
Blood Pressure; Exercise
University of Sao Paulo
2007-05 PHASE4
NCT00295542 COMPLETED
Hypertension
University of Vigo
2000-03 PHASE4
NCT00687973 COMPLETED
Hypertension
Novartis Pharmaceuticals
2008-01 PHASE4
NCT00125853 COMPLETED
Hypertension
Imperial College London
2006-07
NCT00813722 UNKNOWN
Blood Pressure
University of Sao Paulo
1999-03 PHASE4
NCT00263393 COMPLETED
Myocardial Infarction; Angina Pectoris; Cerebrovascular Accidents; Diabetes Mellitus
The George Institute
2005-12 PHASE4
NCT02441842 COMPLETED
Perioperative Hypertension
Milton S. Hershey Medical Center
2006-03 PHASE4
NCT00443794 COMPLETED
Cardiovascular Diseases
St. John's Research Institute
2007-03
NCT00108082 COMPLETED
Hypertrophy, Left Ventricular
GlaxoSmithKline
2005-01 PHASE3
NCT01295047 COMPLETED
Marfan Syndrome
Cardiff University
2006-07 PHASE4
NCT00396656 COMPLETED
Hypertension
Novartis
2005-12 PHASE3
NCT00507663 COMPLETED
Post Operative Cognitive Dysfunction
Icahn School of Medicine at Mount Sinai
2002-09 PHASE4
NCT00202358 UNKNOWN
Surgery
Saini Foundation
2002-11 PHASE4
NCT00145210 COMPLETED
Hypertension
Mylan Bertek Pharmaceuticals
2005-04 PHASE3
NCT00171132 COMPLETED
Hypertension
Novartis
2004-08 PHASE4
NCT02262533 COMPLETED
N/A - Healthy Subjects
Bristol-Myers Squibb
2007-06 PHASE1
NCT00310778 COMPLETED
Healthy
Assistance Publique - Hôpitaux de Paris
2006-03 PHASE1
NCT00262236 COMPLETED
Hypertension
Novartis
2005-11 PHASE3
NCT00147563 COMPLETED
Hypertension
Pfizer
2003-10 PHASE4
NCT00232882 COMPLETED
Hypertension
Institut de Recherches Cliniques de Montreal
2003-12 PHASE4
NCT00171756 COMPLETED
Hypertension
Novartis
2004-06 PHASE4
NCT00772499 COMPLETED
Hypertension
Daiichi Sankyo
2002-11 PHASE4
NCT00775580 COMPLETED
Healthy
Ranbaxy Laboratories Limited
2005-05
NCT00529750 COMPLETED
Hypertension
Sanofi
2002-07 PHASE4
NCT00140959 COMPLETED
Hypertension
Organon and Co
2003-02-01 PHASE4
NCT00541684 COMPLETED
Hypertension
Organon and Co
2001-07-11 PHASE3
NCT00338260 COMPLETED
Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)
Organon and Co
1995-06 PHASE3
NCT00946725 COMPLETED
Angina; Hypertension
Sandoz
2000-11 PHASE1
NCT00389168 COMPLETED
Hypertension
Karolinska Institutet
1995-04 PHASE2; PHASE3
NCT00913965 COMPLETED
Hypertension
Sandoz
1989-07 PHASE1
NCT00000513 COMPLETED
Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
National Heart, Lung, and Blood Institute (NHLBI)
1984-04 PHASE3
NCT00185094 COMPLETED
Hypertension; Insulin Resistance; Metabolic Syndrome
Daiichi Sankyo
2004-02 PHASE4
NCT00133692 COMPLETED
Hypertension; Coronary Artery Disease
University of Florida
1997-09 PHASE4
NCT00185185 COMPLETED
Essential Hypertension; Atherosclerotic Cardiovascular Disease
Sankyo Pharma Gmbh
2001-11 PHASE3
NCT00200421 COMPLETED
Hypertension
Mylan Bertek Pharmaceuticals
2002-05 PHASE2
NCT00151138 COMPLETED
Hypertension
University of Pittsburgh
2002-09
NCT00202566 COMPLETED
Angina Pectoris
Institut de Recherches Internationales Servier
2005-06 PHASE3
NCT00000514 COMPLETED
Cardiovascular Diseases; Cerebrovascular Disorders; Heart Diseases; Hypertension
National Heart, Lung, and Blood Institute (NHLBI)
1984-06 PHASE3
NCT00158093 COMPLETED
Hypertension
Mylan Bertek Pharmaceuticals
2003-06 PHASE1
NCT00549133 COMPLETED
Hypertension; Diabetes Mellitus Type 2
Sanofi
2003-10 PHASE4
NCT00000478 COMPLETED
Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
National Heart, Lung, and Blood Institute (NHLBI)
1990-11 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-12-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atenolol functions as a selective antagonist of human β1-adrenoceptors, binding the receptor to block endogenous catecholamine signaling and downstream cyclic adenosine monophosphate production in cardiac tissue. This inhibition decreases heart rate and myocardial contractility, thereby reducing systemic blood pressure and providing clinical efficacy in conditions such as essential hypertension, stable angina pectoris, and atrial fibrillation.

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>).

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