Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA)
NCT ID: NCT01638663
Last Updated: 2014-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2012-05-31
2014-03-31
Brief Summary
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Detailed Description
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Treatment with V2-receptor antagonists increases vasopressin concentration in plasma that stimulates V1-receptors in the vascular bed. This may change both central and peripheral hemodynamics and plasma concentration of vasoactive hormones. Changes in hemodynamics and hormone concentration may consequently change renal sodium and water handling.
The nitric oxide system plays a central role in both renal sodium and water handling and regulation of vascular tone and blood pressure.
The effects of tolvaptan the circulation and kidneys is investigated by using measurements of biomarkers specific for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of tolvaptan and L-NMMA infusion.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Tolvaptan
Oral administration of 15 mg Tolvaptan on each examination day.
Tolvaptan
15 mg pr day for 1 day
Placebo
Oral administration of 15 mg Unikalk tablet on each examination day.
Placebo
1 tablet Unikalk 1 pr day for 1 day
Interventions
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Tolvaptan
15 mg pr day for 1 day
Placebo
1 tablet Unikalk 1 pr day for 1 day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) 18,5-30 kg/m2
Exclusion Criteria
* 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)
18 Years
40 Years
ALL
Yes
Sponsors
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Regional Hospital Holstebro
OTHER
Responsible Party
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Erling Bjerregaard Pedersen
Professor, MD, Dr.Sci.
Principal Investigators
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Safa Therwani, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Medicinsk Forskning
Locations
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Safa Therwani
Holstebro, , Denmark
Countries
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Other Identifiers
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SAFA-1-2012
Identifier Type: -
Identifier Source: org_study_id
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