L-NMMA Dose-response Study in Healthy Subjects
L-NMMA's Effect on Renal and Cardiovascular Variables in Healthy Subjects. A Randomized, Placebo-controlled Crossover Study.
2 other identifiers
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 21, 2011
February 1, 2011
4 months
February 17, 2010
February 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic blood pressure
6 hours
Secondary Outcomes (7)
GFR
6 hours
Arterial Stiffness
6 hours
Fractional excretion of sodium
6 hours
Fractional excretion of potassium
6 hours
Plasma renin concentration
6 hour
- +2 more secondary outcomes
Study Arms (4)
Isotonic saline infusion
PLACEBO COMPARATORIntravenous L-NMMA dose 2
ACTIVE COMPARATORIntravenous L-NMMA dose 3
ACTIVE COMPARATORIntravenous L-NMMA dose 1
ACTIVE COMPARATORInterventions
3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour
Isotonic saline solution IV priming dose + IV infusion for 1 hour
Eligibility Criteria
You may qualify if:
- Healthy males
- Age 18-35 years
- BMI 18.5-30.0
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departments of Medical Research
Holstebro, Holstebro, 7500, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 18, 2010
Study Start
February 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 21, 2011
Record last verified: 2011-02