Conivaptan HCl Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 770

Clinical Trials

Conivaptan HCl has been evaluated across numerous clinical trials spanning Phase 1 to Phase 4. Supported by both pharmaceutical industry sponsors and major academic medical centers, these active, completed, terminated, and withdrawn studies investigate indications including hyponatremia, acute and chronic heart failure, liver disease, renal impairment, and cerebral edema associated with stroke or intracerebral hemorrhage.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03000283	COMPLETED	Cerebral Hemorrhage; Cerebral Edema; Intracerebral Hemorrhage; Stroke	Jesse Corry	2017-03-22	PHASE1
NCT03000283	Completed	Cerebral Hemorrhage\|Cerebral Edema\|Intracerebral Hemorrhage\|Stroke	Jesse Corry\|Allina Health System	2017-03-22	Phase 1
NCT01954290	WITHDRAWN	Acute Cerebrovascular Accident; Cerebral Edema	University of Florida	2015-09	PHASE2
NCT01752543	COMPLETED	Heart Failure	Finn Gustafsson	2013-12	PHASE4
NCT01370148	COMPLETED	Liver Disease	Cumberland Pharmaceuticals	2011-04	PHASE1
NCT01451411	TERMINATED	Hyponatremia	Cumberland Pharmaceuticals	2012-02	PHASE3
NCT01370148	Completed	Liver Disease	Cumberland Pharmaceuticals	2011-04	Phase 1
NCT00811486	WITHDRAWN	Right Heart Failure; Pulmonary Hypertension	University of Colorado, Denver	2009-01
NCT00887627	COMPLETED	Kidney Diseases; Hyponatremia	Cumberland Pharmaceuticals	2009-04	PHASE1
NCT00930202	COMPLETED	Severe Traumatic Brain Injury	University of Washington	2009-08	PHASE1
NCT00806910	WITHDRAWN	Heart Failure	Albert Einstein Healthcare Network	2008-10	PHASE4
NCT00851227	COMPLETED	Liver Disease; Hyponatremia	Cumberland Pharmaceuticals	2009-02	PHASE1
NCT00727090	TERMINATED	Hyponatremia	Northwestern University	2008-08	PHASE4
NCT00924014	UNKNOWN	Heart Failure	Hennepin County Medical Center, Minneapolis	2009-07
NCT00684164	WITHDRAWN	Hyponatremia	Columbia University	2008-05	PHASE3
NCT00843986	TERMINATED	Hyponatremia; Acute Decompensated Heart Failure	Cumberland Pharmaceuticals	2009-04	PHASE3
NCT00887627	Completed	Kidney Diseases\|Hyponatremia	Cumberland Pharmaceuticals	2009-04	Phase 1
NCT00851227	Completed	Liver Disease\|Hyponatremia	Cumberland Pharmaceuticals	2009-02	Phase 1
NCT00592475	COMPLETED	Liver Cirrhosis	Cumberland Pharmaceuticals	2007-12	PHASE2
NCT00435591	COMPLETED	Hyponatremia; Euvolemia; Hypervolemia	Cumberland Pharmaceuticals	2007-01	PHASE4
NCT00478192	COMPLETED	Hyponatremia	Cumberland Pharmaceuticals	2007-04	PHASE3
NCT00379847	COMPLETED	Hyponatremia	Cumberland Pharmaceuticals	2004-02	PHASE3
NCT00057356	COMPLETED	Chronic Heart Failure	Cumberland Pharmaceuticals	2002-11	PHASE2

(data from https://clinicaltrials.gov, updated on 2020-04-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Conivaptan HCl functions as a dual arginine vasopressin V1A and V2 receptor antagonist, competitively binding to these receptors to inhibit vasopressin-stimulated intracellular signaling pathways. This dual blockade suppresses V2-mediated aquaporin-2 translocation in renal collecting ducts to promote solute-free water excretion while preventing V1A-mediated vascular smooth muscle constriction, providing physiological rationale for its clinical use in managing hyponatremia, heart failure, and cerebral edema.

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>).