L-NMMA Dose-response Study in Healthy Subjects
This study has been completed.
Sponsor:
Regional Hospital Holstebro
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01070940
First received: February 17, 2010
Last updated: February 18, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: NG-monomethyl-L-arginine (L-NMMA) Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
| Official Title: | L-NMMA's Effect on Renal and Cardiovascular Variables in Healthy Subjects. A Randomized, Placebo-controlled Crossover Study. |
Resource links provided by NLM:
Further study details as provided by Regional Hospital Holstebro:
Primary Outcome Measures:
- Systolic blood pressure [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- GFR [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Arterial Stiffness [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Fractional excretion of sodium [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Fractional excretion of potassium [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Plasma renin concentration [ Time Frame: 6 hour ] [ Designated as safety issue: No ]
- Plasma angiotensin II [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Plasma aldosterone [ Time Frame: 6 hour ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | February 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Isotonic saline infusion |
Drug: Placebo
Isotonic saline solution IV priming dose + IV infusion for 1 hour
|
| Active Comparator: Intravenous L-NMMA dose 2 |
Drug: NG-monomethyl-L-arginine (L-NMMA)
4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour
|
| Active Comparator: Intravenous L-NMMA dose 3 |
Drug: NG-monomethyl-L-arginine (L-NMMA)
6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour
|
| Active Comparator: Intravenous L-NMMA dose 1 |
Drug: NG-monomethyl-L-arginine (L-NMMA)
3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy males
- Age 18-35 years
- BMI 18.5-30.0
Exclusion Criteria:
- Tobacco or illicit drug use
- Current use of any prescription or non-prescription drugs
- Alcohol abuse
- History of heart failure, lever failure, chronic kidney disease or cerebral insult
- Diabetes
- Clinical or paraclinical signs of infection
- Pathologic ECG
- Ambulatory blood pressure >140/90 mmHg
- Abnormal blood or urin screening tests
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070940
Locations
| Denmark | |
| Departments of Medical Research | |
| Holstebro, Denmark, 7500 | |
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Thomas Larsen, M.D., Departments of Medical Research, Holstebro Hospital |
| ClinicalTrials.gov Identifier: | NCT01070940 History of Changes |
| Other Study ID Numbers: | EBP.FHC.1.2009, 2009-017001-11 |
| Study First Received: | February 17, 2010 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Regional Hospital Holstebro:
|
L-NMMA blood pressure arterial stiffness pulse wave velocity |
augmentation index dose-response healthy subjects GFR |
Additional relevant MeSH terms:
|
Omega-N-Methylarginine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013