Clinical Trials
Multiple clinical trials evaluate the therapeutic application of bisoprolol across various cardiovascular conditions, including heart failure, arterial hypertension, coronary artery disease, acute coronary syndrome, and postoperative atrial fibrillation. These studies encompass Phase 2, Phase 4, and non-phased observational designs, spanning recruiting, completed, and unknown recruitment statuses. Sponsored by both academic institutions and pharmaceutical companies, these investigations reflect ongoing efforts to optimize bisoprolol treatment protocols in clinical practice.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06004453 | Recruiting | Heart Failure |
Novartis Pharmaceuticals|Novartis |
2023-04-04 | -- |
| NCT05536284 | Completed | Acute Coronary Syndrome |
Damanhour University|Alexandria University |
2021-09-01 | Phase 2 |
| NCT05730413 | Recruiting | Coronary Artery Bypass Grafting|Postoperative Atrial Fibrillation|Coronary Artery Disease |
Cairo University |
2021-08-25 | Phase 4 |
| NCT04656847 | Completed | Coronary Artery Disease|Myocardial Infarction|Arterial Hypertension |
Servier Russia |
2021-03-01 | -- |
| NCT03730116 | Completed | Arterial Hypertension|CHD - Coronary Heart Disease |
Servier Russia |
2018-11-14 | -- |
| NCT03644446 | Unknown status | Heart Failure With Reduced Ejection Fraction |
University Hospital Caen |
2017-11-02 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
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>).