Effects of the diuretic tolvaptan on nitric oxide system

Effects of tolvaptan on renal sodium and water handling and circulation during inhibition of the nitric oxide system in healthy subjects - SAFA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001169-33-DK

Enrollment

Registered

2012-06-14

Start date

2012-07-02

Completion date

Unknown

Last updated

2021-04-19

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

Conditions

SIADH (Syndrome of inappropriate ADH production) Overhydration Hyponatrimia MedDRA version: 14.1 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT Classification code 10040626 Term: SIADH System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: Samsca Product Name: Tolvaptan Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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): CH2O (Free water clereance);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 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): CH2O (Free water clereance);Timepoint(s) of evaluation of this end point: End of study

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Secondary

Measure	Time frame
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) Central blood pressure, pulse wave velocity and augmentation index, 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	—

Measure

Time frame

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) Central blood pressure, pulse wave velocity and augmentation index, 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

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Countries

Denmark

Contacts

Public ContactDepartment of Medical Research

Holstebro Hospital

frchri@rm.dk4578436589

Outcome results

None listed

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