NCT03910231|CompletedPhase 1DMCFDA Drug
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Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
February 1, 2012
Actual (reported)Primary Completion
September 30, 2014
Actual (reported)Study Completion
February 1, 2015
Actual (reported)Vasopressin has primarily been considered to be a water and osmosis regulating hormone that mediates its effects on renal aquaporin channels. Recent data suggest that vasopressin, through its V2 receptor, may also modulate sodium homeostasis. The purpose of this human physiology study was to test whether antagonism of the V2R alters urine sodium excretion in normal healthy volunteers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2012
Actual (reported)September 30, 2014
Actual (reported)February 1, 2015
Actual (reported)April 9, 2019
Actual (reported)April 10, 2019
Actual (reported)Acute intravenous saline response
Urine sodium excretion measured in response to saline infusion
6 hours
Dietary salt response
6 days
Placebo
15mg Tolvaptan
30mg Tolvaptan
Stockand JD. Vasopressin regulation of renal sodium excretion. Kidney Int. 2010 Nov;78(9):849-56. doi: 10.1038/ki.2010.276. Epub 2010 Aug 25.
Bankir L, Bichet DG, Bouby N. Vasopressin V2 receptors, ENaC, and sodium reabsorption: a risk factor for hypertension? Am J Physiol Renal Physiol. 2010 Nov;299(5):F917-28. doi: 10.1152/ajprenal.00413.2010. Epub 2010 Sep 8.
Blanchard A, Frank M, Wuerzner G, Peyrard S, Bankir L, Jeunemaitre X, Azizi M. Antinatriuretic effect of vasopressin in humans is amiloride sensitive, thus ENaC dependent. Clin J Am Soc Nephrol. 2011 Apr;6(4):753-9. doi: 10.2215/CJN.06540810. Epub 2011 Jan 13.
Jonathan S Williams, MD, MMSc
Brigham and Women's Hospital
30 participants (actual enrollment reported by the registry).
First Submitted
April 9, 2019
First Posted
April 10, 2019
Study Start
Megavec 400 mg (Imatinib Mesylate) in Healthy Adult Male Volunteers
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Gheorghiade M, Niazi I, Ouyang J, Czerwiec F, Kambayashi J, Zampino M, Orlandi C; Tolvaptan Investigators. Vasopressin V2-receptor blockade with tolvaptan in patients with chronic heart failure: results from a double-blind, randomized trial. Circulation. 2003 Jun 3;107(21):2690-6. doi: 10.1161/01.CIR.0000070422.41439.04. Epub 2003 May 12.
Hauptman PJ, Zimmer C, Udelson J, Shoaf SE, Mallikaarjun S, Bramer SL, Orlandi C. Comparison of two doses and dosing regimens of tolvaptan in congestive heart failure. J Cardiovasc Pharmacol. 2005 Nov;46(5):609-14. doi: 10.1097/01.fjc.0000180899.24865.b6.
February 1, 2012
Actual (reported)Primary Completion
September 30, 2014
Actual (reported)Study Completion
February 1, 2015
Actual (reported)Last Updated
April 10, 2019
Record last verified: 2019-04
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