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.

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. - DOVA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003800-38-DK

Enrollment

Registered

2013-12-09

Start date

2014-02-24

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia SIADH (Syndrome of Inappropriate Antidiuretic Hormone secretion) MedDRA version: 14.1 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 100000004861 MedDRA version: 14.1 Level: LLT Classification code 10040626 Term: SIADH System Organ Class: 100000004860

Interventions

Trade Name: Samsca Product Name: Tolvaptan Product Code: C03XA01 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Current Sponsor code: C03XA01 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. ;Primary end point(s): CH2O ( free water clearance) ;Timepoint(s) of evaluation of this end point: End of study.	—

Measure

Time frame

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. ;Primary end point(s): CH2O ( free water clearance) ;Timepoint(s) of evaluation of this end point: End of study.

—

Secondary

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactDepartment of Medical Research

Holstebro Hospital

safatherwani@hotmail.com004578436582

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026