Clinical Trials

Numerous clinical trials evaluate bisoprolol across Early Phase 1 through Phase 4 and unclassified stages, focusing primarily on cardiovascular conditions—including arterial hypertension, coronary artery disease, myocardial infarction, heart failure, and atrial fibrillation—as well as secondary complications in Duchenne muscular dystrophy and breast cancer cardiotoxicity. Sponsored by diverse entities ranging from pharmaceutical corporations to academic medical centers, these studies encompass various recruitment statuses, including completed, actively recruiting, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06643221 RECRUITING
Leukemia; Hematopoetic Stem Cell Transplantation; Donor Lymphocyte Infusion; CAR T-Cell Therapy; Lymphoma; Cell Therapy
University of Arizona
 2018-01-24 EARLY_PHASE1
NCT04432610 WITHDRAWN
Bisoprolol Adverse Reaction; Nebivolol Adverse Reaction
Clinical Hospital Center Zemun
 2030-01 PHASE4
NCT07491718 RECRUITING
Takotsubo Cardiomyopathy
University of Edinburgh
 2025-08-08
NCT07568574 ENROLLING_BY_INVITATION
Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes
Enhanced Emirates Limited
 2026-03-12
NCT06562582 RECRUITING
Myocardial Infarct
Vastra Gotaland Region
 2025-01-06 PHASE4
NCT07029906 RECRUITING
Side-Effect; Heart Failure
Imperial College London
 2025-04-29
NCT05569382 RECRUITING
Non-obstructive Hypertrophic Cardiomyopathy
Morten Steen Kvistholm Jensen
 2022-08-10 PHASE4
NCT06276127 NOT_YET_RECRUITING
Atrial Fibrillation With Rapid Ventricular Response; Atrial Flutter With Rapid Ventricular Response
Oman Medical Speciality Board
 2025-04 PHASE3
NCT07103655 NOT_YET_RECRUITING
Hypertrophic Cardiomyopathy (HCM)
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2026-01-01 PHASE4
NCT06035978 UNKNOWN
Cardiovascular Diseases; Heart Failure With Reduced Ejection Fraction
University Hospital Ostrava
 2024-03 PHASE4
NCT05880056 UNKNOWN
Essential Hypertension
Genuine Research Center, Egypt
 2024-08-08 PHASE4
NCT03778554 ACTIVE_NOT_RECRUITING
Acute Myocardial Infarction; Non-ST Elevation Myocardial Infarction (nSTEMI); ST Elevation Myocardial Infarction
Bispebjerg Hospital
 2018-12-17 PHASE4
NCT03917914 COMPLETED
Chronic Obstructive Pulmonary Disease; Cardiovascular Diseases
The George Institute
 2020-06-30 PHASE3
NCT06657404 RECRUITING
Atrial Fibrillation (AF)
Yumei Xue
 2024-10-23
NCT07327749 COMPLETED
Hypertension
Shiraz University of Medical Sciences
 2022-10-01 PHASE4
NCT05294887 UNKNOWN
Coronary Microvascular Dysfunction; Microvascular Angina; Vasospasm, Coronary; Vasospastic Angina; Prinzmetal Angina; Coronary Artery Disease
Charite University, Berlin, Germany
 2022-03-04 PHASE4
NCT01868880 WITHDRAWN
Heart Rate Control in ICD Patients With Heart Failure
Policlinico Casilino ASL RMB
 2016-02 PHASE4
NCT03278509 UNKNOWN
Acute Myocardial Infarction; Non-ST Elevation Myocardial Infarction; ST Elevation Myocardial Infarction
Karolinska Institutet
 2017-09-11 PHASE4
NCT05730413 UNKNOWN
Coronary Artery Bypass Grafting; Postoperative Atrial Fibrillation; Coronary Artery Disease
Cairo University
 2021-08-25 PHASE4
NCT03779646 UNKNOWN
Duchenne Muscular Dystrophy; Cardiomyopathy, Dilated
Peking Union Medical College Hospital
 2019-01-16 PHASE2; PHASE3
NCT04588935 COMPLETED
Women With Breast Cancer
State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
 2019-07-01 PHASE2
NCT05540600 UNKNOWN
Atrial Fibrillation; Left Atrial Rhythm
University of Monastir
 2022-09-12 PHASE3
NCT05430048 COMPLETED
Bleeding
Zagazig University
 2022-07-01 PHASE2
NCT04513509 COMPLETED
Atrial Fibrillation; Rate Control; Cardiopulmonary Exercise Test
National Taiwan University Hospital
 2020-10-21
NCT05536271 COMPLETED
Acute Coronary Syndrome
Damanhour University
 2021-09-01 PHASE2
NCT02236806 UNKNOWN
Breast Cancer; Cardiotoxicity
Azienda Ospedaliero-Universitaria Careggi
 2015-07 PHASE3
NCT05536284 COMPLETED
Acute Coronary Syndrome
Damanhour University
 2021-09-01 PHASE2
NCT04823442 COMPLETED
Type 2 Diabetes
Université de Sherbrooke
 2021-01-21
NCT04356196 UNKNOWN
Endoscopic Sinus Surgery; Heart Rate; Blood Loss
Assiut University
 2021-06-15 EARLY_PHASE1
NCT05175066 COMPLETED
Cardiomyopathies; Chemotherapy Effect; Diastolic Dysfunction; Systolic Dysfunction
Shahid Beheshti University of Medical Sciences
 2020-11-12 PHASE3
NCT04085562 COMPLETED
Hypertension, Renal
Alexandria University
 2019-09-01 PHASE4
NCT02398929 COMPLETED
Hypertension
Chinese University of Hong Kong
 2013-01 PHASE4
NCT03701880 UNKNOWN
Heart Failure With Reduced Ejection Fraction; Decompensated Heart Failure
Ain Shams University
 2018-09-16
NCT02380053 COMPLETED
Chronic Obstructive Pulmonary Disease
University of Dundee
 2016-06-07 PHASE4
NCT02391337 COMPLETED
Permanent Atrial Fibrillation
University of Birmingham
 2016-12-20 PHASE4
NCT03026088 TERMINATED
Heart Failure
Merck KGaA, Darmstadt, Germany
 2017-03-21 PHASE4
NCT05288400 COMPLETED
Essential Hypertension
Servier
 2018-05-14 PHASE3
NCT03800264 COMPLETED
Prevention; Atrial Fibrillation; CABG
Ain Shams University
 2018-05-02 PHASE4
NCT02355821 COMPLETED
Osteopenia; Arterial Hypertension
National Research Center for Preventive Medicine
 2015-04
NCT03485482 COMPLETED
Cardiovascular Diseases
Ain Shams University
 2018-03-01 PHASE3
NCT02832973 COMPLETED
Hypertension Resistant to Conventional Therapy
Sao Jose do Rio Preto Medical School
 2015-09 PHASE4
NCT03226275 COMPLETED
Healthy
Merck KGaA, Darmstadt, Germany
 2017-08-09 PHASE1
NCT00882856 COMPLETED
Clozapine-induced Sinustachycardia
University of Aarhus
 2009-04
NCT03850093 COMPLETED
Blood Pressure
Zagazig University
 2015-08 PHASE4
NCT01656005 COMPLETED
Chronic Obstructive Pulmonary Disease
University of Dundee
 2012-08 PHASE4
NCT02137733 UNKNOWN
Chronic Heart Failure
Mebix Inc
 2013-06
NCT02171988 COMPLETED
Postural Orthostatic Tachycardia Syndrome
Seoul National University Hospital
 2014-03 PHASE4
NCT01016886 UNKNOWN
Breast Cancer; Heart Failure
University of Alberta
 2010-09 PHASE1; PHASE2
NCT02369081 UNKNOWN
Hypertension, Resistant to Conventional Therapy
University of Cambridge
 2009-05 PHASE4
NCT01977794 COMPLETED
Hypertension
Merck KGaA, Darmstadt, Germany
 2014-03 PHASE3
NCT01162902 UNKNOWN
Stable Angina
Seoul National University Hospital
 2013-09 PHASE4
NCT01955759 UNKNOWN
Patients With Coronary Artery Disease Scheduled for by Pass Surgery
Heart Center BH Tuzla
 2013-12 EARLY_PHASE1
NCT01939509 COMPLETED
Hypertension; Metabolic Syndrome
Hospital Italiano de Buenos Aires
 2012-02 PHASE4
NCT03011775 COMPLETED
Adverse Effect; Atherosclerosis, Coronary; Insulin Resistance Syndrome
Ukrainian Medical Stomatological Academy
 2012-11 PHASE4
NCT01579058 TERMINATED
Aortic Stenosis
Asan Medical Center
 2012-07 PHASE4
NCT01508325 COMPLETED
Hypertension
Merck KGaA, Darmstadt, Germany
 2011-12 PHASE4
NCT01246037 UNKNOWN
Idiopathic Pulmonary Arterial Hypertension
Amsterdam UMC, location VUmc
 2011-02 PHASE1; PHASE2
NCT02106286 COMPLETED
Abdominal Aortic Aneurysm Patients Under Surveillance
Michelle Mossa
 2011-02 EARLY_PHASE1
NCT01925300 WITHDRAWN
Healthy
HK inno.N Corporation
 2013-07 PHASE1
NCT01066039 COMPLETED
Hypertension; Diabetes Mellitus, Type II
Merck KGaA, Darmstadt, Germany
 2010-04 PHASE4
NCT01243827 UNKNOWN
Hypertension
Yoshio Matsui
 2010-11 PHASE4
NCT01744873 COMPLETED
Fed
IPCA Laboratories Ltd.
 2012-08 PHASE1
NCT01741623 COMPLETED
Fasting
IPCA Laboratories Ltd.
 2012-08 PHASE1
NCT01074307 COMPLETED
Heart Failure, Congestive
Merck KGaA, Darmstadt, Germany
 2009-10 PHASE4
NCT01030458 COMPLETED
Blood Pressure
KU Leuven
 2010-09 PHASE4
NCT01762436 COMPLETED
Untreated Essential Hypertension
Ruijin Hospital
 2010-11 PHASE4
NCT01251146 COMPLETED
Hypertension
Merck KGaA, Darmstadt, Germany
 2010-11 PHASE4
NCT00562952 COMPLETED
Diabetes Mellitus; Heart Failure; Coronary Artery Disease
Medical University of Vienna
 2007-11 PHASE2; PHASE3
NCT01190436 COMPLETED
Hypertension
Merck KGaA, Darmstadt, Germany
 2009-12 PHASE4
NCT01079962 COMPLETED
Hypertension
Merck KGaA, Darmstadt, Germany
 2009-12 PHASE4
NCT01273298 COMPLETED
Chronic Obstructive Pulmonary Disease
Laval University
 2008-06
NCT01104558 COMPLETED
Chronic Heart Failure
Merck KGaA, Darmstadt, Germany
 2008-12 PHASE4
NCT01284868 COMPLETED
Healthy Volunteers; Pharmacodynamics of Mirabegron
Astellas Pharma Inc
 2009-07 PHASE1
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
NCT00702156 TERMINATED
Heart Failure; Chronic Obstructive Pulmonary Disease
NHS Greater Glasgow and Clyde
 2005-03 PHASE2
NCT02256722 COMPLETED
Healthy
Boehringer Ingelheim
 2005-10 PHASE1
NCT00323973 COMPLETED
Chagas Cardiomyopathy; Chronic Heart Failure
Fundación Cardiovascular de Colombia
 2003-07 PHASE3
NCT03276598 COMPLETED
Hypertension; Pharmacogenetics
Helsinki University Central Hospital
 1999-11-25 PHASE4
NCT00517725 COMPLETED
Chronic Heart Failure
Centro Cardiologico Monzino
 2007-07 PHASE4
NCT00382421 COMPLETED
Myocardial Ischemia
Luzerner Kantonsspital
 1992-02

(data from https://clinicaltrials.gov, updated on 2026-06-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bisoprolol fumarate selectively binds to and inhibits the β1-adrenergic receptor, preventing endogenous catecholamines from stimulating intracellular cyclic AMP production and downstream protein kinase A signaling pathways in cardiac tissue. This blockade reduces myocardial contractility and heart rate, thereby decreasing cardiac workload and oxygen demand to mitigate clinical conditions such as arterial hypertension, coronary artery disease, and chronic heart failure.

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.