NCT02078973

Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)

The Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Circulatory System, During Basal Conditions and During Inhibition of the Nitric Oxide System in Healthy Subjects. A Dose-response Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Regional Hospital Holstebro · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which stimulates V1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones. The purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA).

Conditions

• Nephropathy

Interventions

Type	Name	Description
DRUG	15 mg tolvaptan	15 mg pr day for 1 day
DRUG	30 mg tolvaptan	30 mg pr day for 1 day
DRUG	45 mg tolvaptan	45 mg pr day for 1 day
DRUG	Placebo	1 tablet Unikalk pr day for 1 day

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-03-05
• Last updated: 2017-03-01

Locations

1 site across 1 country: Denmark