Vardenafil HCl Trihydrate Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated vardenafil across Early Phase I through Phase IV studies for indications including erectile dysfunction, pulmonary hypertension, and central nervous system malignancies such as glioma and brain metastases. Sponsored by a combination of academic institutions, university hospitals, and major pharmaceutical corporations, these initiatives encompass diverse recruitment statuses. These range from completed studies, such as a Phase III trial evaluating treatment for pulmonary arterial hypertension, to terminated protocols, such as an early-phase pilot study assessing phosphodiesterase-V inhibition to increase intratumoral chemotherapy concentrations in high-grade glioma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02279992	Terminated	Glioma\|Brain Neoplasms\|Brain Metastasis	Cedars-Sinai Medical Center	2012-03-27	Early Phase 1
NCT01348880	Completed	Erectile Dysfunction	Bayer\|GlaxoSmithKline\|Merck Sharp & Dohme LLC	2011-05	Phase 1
NCT01106118	Completed	Erectile Dysfunction	Bayer	2010-01	--
NCT01084187	Completed	Erectile Dysfunction\|Arterial Hypertension\|Endothelial Dysfunction	Hospital Universitario Pedro Ernesto	2010-01	Phase 4
NCT00738400	Completed	Erectile Dysfunction\|Metabolic Syndrome	Bayer	2008-11	Phase 4
NCT00718952	Completed	Pulmonary Hypertension	Tongji University	2008-07	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vardenafil selectively binds to phosphodiesterase type 5 (PDE5) and inhibits its catalytic activity, preventing the degradation of cyclic guanosine monophosphate (cGMP). This accumulation of intracellular cGMP promotes vascular smooth muscle relaxation and enhanced blood perfusion, providing the pharmacological basis for its clinical investigation in conditions such as erectile dysfunction, pulmonary arterial hypertension, and neuro-oncological drug delivery.

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>).