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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003800-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg tolvaptan | Active Comparator | Oral administration of 15 mg tolvaptan on each examination day. |
|
| 30 mg tolvaptan | Active Comparator | Oral administration of 30 mg tolvaptan on each examination day. |
|
| 45 mg tolvaptan | Active Comparator | Oral administration of 45 mg tolvaptan on each examination day. |
|
| Placebo | Placebo Comparator | Oral administration of a Unikalk tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15 mg tolvaptan | Drug | 15 mg pr day for 1 day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| CH2O | Measurement of H2O clearance at baseline, during and after L-NMMA infusion | 5-6 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Urine biomarkers(Aquaporins and Epithelial Sodium Channels γ) | 5-6 Hours | |
| Central and brachial blood pressure | 5-6 Hours | |
| Augmentation Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank H Mose, MD, PhD | Department of medical research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of medical research | Holstebro | 7500 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28288570 | Derived | 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. |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 30 mg tolvaptan | Drug | 30 mg pr day for 1 day |
|
|
| 45 mg tolvaptan | Drug | 45 mg pr day for 1 day |
|
|
| Placebo | Drug | 1 tablet Unikalk pr day for 1 day |
|
|
| 5-6 Hours |
| Vasoactive Hormones( Angiotensin II, Aldosterone, Endothelin, Atrial Natriuretic Peptide, Brain Natriuretic Peptide, Arginin Vasopressin) | 5-6 Hours |
| Fractional sodium excretion | Measurement of Sodium excretion at baseline, during and after L-NMMA infusion. | 5-6 Hours |
| D052801 | Male Urogenital Diseases |