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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017001-11 | EudraCT Number |
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The purpose of this study is to investigate the effect of different levels of nitric oxide inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor of the nitric oxide synthase, is administered as bolus injection followed by continuous infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotonic saline infusion | Placebo Comparator |
| |
| Intravenous L-NMMA dose 2 | Active Comparator |
| |
| Intravenous L-NMMA dose 3 | Active Comparator |
| |
| Intravenous L-NMMA dose 1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NG-monomethyl-L-arginine (L-NMMA) | Drug | 3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| GFR | 6 hours | |
| Arterial Stiffness | 6 hours | |
| Fractional excretion of sodium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Larsen, M.D. | Departments of Medical Research, Holstebro Hospital | Principal Investigator |
| Frank H Christensen, M.D. | Departments of Medical Research, Holstebro Hospital | Principal Investigator |
| Erling B Pedersen, Dr.med. | Departments of Medical Research, Holstebro Hospital | Principal Investigator |
| Jesper N Bech, Ph.d. | Departments of Medical Research, Holstebro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departments of Medical Research | Holstebro | Holstebro | 7500 | Denmark |
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| ID | Term |
|---|---|
| D019323 | omega-N-Methylarginine |
| ID | Term |
|---|---|
| D001120 | Arginine |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| NG-monomethyl-L-arginine (L-NMMA) | Drug | 6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour |
|
| NG-monomethyl-L-arginine (L-NMMA) | Drug | 4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour |
|
| Placebo | Drug | Isotonic saline solution IV priming dose + IV infusion for 1 hour |
|
| 6 hours |
| Fractional excretion of potassium | 6 hours |
| Plasma renin concentration | 6 hour |
| Plasma angiotensin II | 6 hours |
| Plasma aldosterone | 6 hour |
| D000599 |
| Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |