Effects of the diuretic tolvaptan on nitric oxide system

• Register: EUCTR
• Last refreshed on: 19 April 2021
• Main ID: EUCTR2012-001169-33-DK
• Date of registration: 14/06/2012
• Prospective Registration: Yes
• Primary sponsor: Department of Medical Research
• Public title: Effects of the diuretic tolvaptan on nitric oxide system
• Scientific title: Effects of tolvaptan on renal sodium and water handling and circulation during inhibition of the nitric oxide system in healthy subjects - SAFA
• Date of first enrolment: 02/07/2012
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001169-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: Department of Medical Research
• Affiliation: Holstebro Hospital

• Name: Department of Medical Research
• Affiliation: Holstebro Hospital

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Body processes [G] - Physiological processes [G07]

Intervention(s)

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)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

Main Objective: To Investigate the effects of tolvaptan on the nitric oxide system

Primary end point(s):
CH2O
(Free water clereance)

Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: End of study

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

Secondary ID(s)

SAFA-1-2012

Source(s) of Monetary Support

Public and private funding

Ethics review

Status: Approved
Approval date: 02/07/2012
Contact: