Dabigatran etexilate mesylate Clinical Trials

Size	Price	Qty
25mg	USD 147
100mg	USD 247

Clinical Trials

Multiple completed, observational post-authorization clinical trials sponsored by Boehringer Ingelheim have evaluated dabigatran etexilate mesylate for atrial fibrillation, stroke prophylaxis, and venous thromboembolism. Lacking assigned phase designations, these studies assessed treatment convenience, patient perception, risk minimization effectiveness, and real-world prevention of thromboembolic events following elective orthopedic surgery. Together, these trial records provide post-marketing evidence supporting the safety and utility of this anticoagulant agent across targeted clinical indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02839746	Completed	Atrial Fibrillation	Boehringer Ingelheim	2016-06-13	--
NCT02684981	Completed	Atrial Fibrillation\|Stroke	Boehringer Ingelheim	2015-11-11	--
NCT02433366	Completed	Atrial Fibrillation	Boehringer Ingelheim	2015-01	--
NCT01139658	Completed	Venous Thromboembolism	Boehringer Ingelheim	2010-08	--

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dabigatran etexilate mesylate is an orally active prodrug converted to dabigatran, a selective direct thrombin inhibitor that reversibly binds the active site of thrombin to prevent fibrinogen cleavage and inhibit thrombin-induced platelet aggregation. By suppressing downstream fibrin mesh formation and thrombus propagation, this targeted pathway provides key clinical efficacy in preventing venous thromboembolism and reducing stroke risk in patients with 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>).