The effects of tolvaptan on renal handeling of water and salt, hormones in the blood and the circulation, during blocking of the nitric oxide (NO) system in healthy subjects. A dose-response study.

Phase 1

• Conditions: HyponatremiaSIADH (Syndrome of Inappropriate Antidiuretic Hormone secretion); MedDRA version: 14.1Level: LLTClassification code 10021038Term: HyponatremiaSystem Organ Class: 100000004861; MedDRA version: 14.1Level: LLTClassification code 10040626Term: SIADHSystem Organ Class: 100000004860; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2013-003800-38-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: 2013-12-09
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1) Caucasian men and women
2) age 18-40 years
3)BMI between 18.5 and 30 kg/m2.
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 22
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Arterial hypertension, defined as consultation blood pressure above 140 mmHg systolic and / or 90 mmHg diastolic. 2) Medically important or clinical signs of diseases of the heart, lungs, liver, endocrine organs and brain or neoplastic disease, 3) alcohol or drug abuse, 4) medical treatment except oral contraceptives, 5) smoking, 6) pregnancy or breastfeeding, 7) clinically important abnormalities in blood or urine sample at the inclusion 8) clinically important changes in the electrocardiogram, 9) blood donation for the past month prior to the examination days, and 10) allergy to tolvaptan.

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 of the study is to measure the effects of tolvaptan on: (1) Renal handling of water and sodium (GFR, UV, CH2O, u-AQP2, u-ENaC?, u-cAMP, CNa, FeNa, CK, FEK), (2) vasoactive hormones (PRC, p-AngII, p-Aldo , p-AVP, p-ANP, p-BNP and p-endothelial-I) and (3) Central hemodynamics (cBT, PWV and AI), basal and under basal conditions and during inhibition of the nitric oxide synthesis in healthy subjects in a dose-response study.<br>;Primary end point(s): CH2O ( free water clearance) ;Timepoint(s) of evaluation of this end point: End of study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (1) Renal function (GFR, UV, CH2O, u-AQP2, u-ENaC?, u-cAMP, CNa, FeNa, CK, FEK), (2) vasoactive hormones (PRC, p-AngII, p-Aldo , p-AVP, p-ANP, p-BNP and p-endothelial-I), (3) central hemodynamics (cBT, PWV and AI) amd (4)p-nitrite, p-nitrate, u-nitrite, u-nitrate.;Timepoint(s) of evaluation of this end point: End of study