Effects of the diuretic tolvaptan on nitric oxide system

Phase 1

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10040626Term: SIADHSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Body processes [G] - Physiological processes [G07]; SIADH (Syndrome of inappropriate ADH production)OverhydrationHyponatrimia; MedDRA version: 14.1Level: LLTClassification code 10021038Term: HyponatremiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2012-001169-33-DK
• Lead Sponsor: Department of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-14
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Men and women (fertile women must use contraceptives)
Age 18-40 years
BMI between 18.5-30 kg/m2
Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a)Arterial hypertension (ofiice BP over 140 mmHg systolisc and/or 90 mmHg diastolic)
b)Clincal signs of heart, lung, liver, kidney, brain, endocrine or neplastic diseases
c)Alcoholabuse
d)Drugabuse.
e)Medical treatment, except anticontraceptives
f)Smoking
g)Pregnancy or nursing
h)Clinical important abnormalities in blood or urine samples or during he alt examination
i)Clinical important abnormalities in ECG
j)Bloddonation within a month of first treatment period
k)Allergies towards Tolvaptan.
l)Fertile women must use contraceptives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To Investigate the effects of tolvaptan on the nitric oxide system;Secondary Objective: The purpose is to investigate the effects of tolvaptan on renal sodium and water handling(GFR, UV, CH20, u-AQP2, u-ENaCaß?, u-NCC, u-NK2CC, CNa, FENa, CK, FEK), plasma concentrations of vasoactive hormoner (renin, angiotensin II, aldosterone, atrial natriuretic peptide, brain natriuretic peptide and endotehline), central blood pressure, pulse wave velocity (PWV) og augmentation index, at baseline and during inhibition of nitric oxide synthesis with L-NMMA in healthy subjects;Primary end point(s): <br>CH2O<br>(Free water clereance);Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Kidney function: GFR, UV, CH20, protein excretion from tubular sodium and water channels (u-AQP-2, u-ENaCß, u-ENaC?, u-NCC, u-NK2CC), Sodium excretion (CNa, FENa), potassium excretion (CK, FEK)<br>Central blood pressure, pulse wave velocity and augmentation index,<br>Vasoactive hormones: p-Renin, p-Angiotensin II, p-Aldosterone, p-AVP , p-ANP (atrial natriuretic peptide), p-BNP (brain natriuretic peptide) og p-Endotheline-1;Timepoint(s) of evaluation of this end point: End of study