This trial is active, not recruiting.

Condition nephropathy
Treatments 15 mg tolvaptan, 30 mg tolvaptan, 45 mg tolvaptan, placebo
Phase phase 2
Sponsor Regional Hospital Holstebro
Collaborator Aarhus University Hospital
Start date February 2014
End date July 2015
Trial size 22 participants
Trial identifier NCT02078973, 2013-003800-38, SAFA-1-2014


Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which stimulates V1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones.

The purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
Oral administration of 15 mg tolvaptan on each examination day.
15 mg tolvaptan Samsca
15 mg pr day for 1 day
(Active Comparator)
Oral administration of 30 mg tolvaptan on each examination day.
30 mg tolvaptan Samsca
30 mg pr day for 1 day
(Active Comparator)
Oral administration of 45 mg tolvaptan on each examination day.
45 mg tolvaptan Samsca
45 mg pr day for 1 day
(Placebo Comparator)
Oral administration of a Unikalk tablet
placebo Unikalk
1 tablet Unikalk pr day for 1 day

Primary Outcomes

time frame: 5-6 Hours

Secondary Outcomes

Urine biomarkers(Aquaporins and Epithelial Sodium Channels γ)
time frame: 5-6 Hours
Central and brachial blood pressure
time frame: 5-6 Hours
Augmentation Index
time frame: 5-6 Hours
Vasoactive Hormones( Angiotensin II, Aldosterone, Endothelin, Atrial Natriuretic Peptide, Brain Natriuretic Peptide, Arginin Vasopressin)
time frame: 5-6 Hours
Fractional sodium excretion
time frame: 5-6 Hours

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

Inclusion Criteria: - Men and women, age 18-40 years - Body Mass Index (BMI) 18,5-30 kg/m2 Exclusion Criteria: - Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease - Neoplastic disease - Drug abuse - Alcohol abuse - Medical treatment except peroral anticontraceptive - Pregnancy - Smoking - Abnormal blood and urine sample - Abnormal ECG - Blood donation within a month before examination - Arterial hypertension (>140 mmHg systolic and/or 90 mmHg diastolic)

Additional Information

Official title 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.
Principal investigator Frank H Mose, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Regional Hospital Holstebro.