Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)
NCT ID: NCT02078973
Last Updated: 2017-03-01
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
15 participants
INTERVENTIONAL
2014-03-01
2016-01-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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15 mg tolvaptan
Oral administration of 15 mg tolvaptan on each examination day.
15 mg tolvaptan
15 mg pr day for 1 day
30 mg tolvaptan
Oral administration of 30 mg tolvaptan on each examination day.
30 mg tolvaptan
30 mg pr day for 1 day
45 mg tolvaptan
Oral administration of 45 mg tolvaptan on each examination day.
45 mg tolvaptan
45 mg pr day for 1 day
Placebo
Oral administration of a Unikalk tablet
Placebo
1 tablet Unikalk pr day for 1 day
Interventions
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15 mg tolvaptan
15 mg pr day for 1 day
30 mg tolvaptan
30 mg pr day for 1 day
45 mg tolvaptan
45 mg pr day for 1 day
Placebo
1 tablet Unikalk 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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Aarhus University Hospital
OTHER
Regional Hospital Holstebro
OTHER
Responsible Party
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Erling Bjerregaard Pedersen
Professor, MD, Dr.Sci.
Principal Investigators
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Frank H Mose, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of medical research
Locations
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Department of medical research
Holstebro, , Denmark
Countries
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References
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Al Therwani S, Rosenbaek JB, Mose FH, Bech JN, Pedersen EB. Effect of tolvaptan on renal water and sodium excretion and blood pressure during nitric oxide inhibition: a dose-response study in healthy subjects. BMC Nephrol. 2017 Mar 13;18(1):86. doi: 10.1186/s12882-017-0501-1.
Other Identifiers
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2013-003800-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SAFA-1-2014
Identifier Type: -
Identifier Source: org_study_id
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