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

NCT02078973 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-03-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Regional Hospital Holstebro

    lead OTHER

Principal Investigators

  • Frank H Mose, MD, PhD · Department of medical research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-01
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078973 on ClinicalTrials.gov