HealthyPhase 1NCT01070940
L-NMMA Dose-response Study in Healthy Subjects
A Phase 1 study testing NG-monomethyl-L-arginine (L-NMMA) in people with Healthy, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NG-monomethyl-L-arginine (L-NMMA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age 18-35 years
- BMI 18.5-30.0
Who cannot join
- 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
Show all 9Show fewer
- Pathologic ECG
- Ambulatory blood pressure >140/90 mmHg
- Abnormal blood or urin screening tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L-NMMA's Effect on Renal and Cardiovascular Variables in Healthy Subjects. A Randomized, Placebo-controlled Crossover Study.
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.
- Conditions
- Healthy
- Being tested
- NG-monomethyl-L-arginine (L-NMMA), Placebo
- Keywords
- L-NMMA, blood pressure, arterial stiffness, pulse wave velocity, augmentation index, dose-response, healthy subjects, GFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG-monomethyl-L-arginine (L-NMMA)Drug
3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour
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
PlaceboDrug
Isotonic saline solution IV priming dose + IV infusion for 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Isotonic saline infusion | Placebo comparator | Not described Receives: Drug: Placebo |
| Intravenous L-NMMA dose 2 | Active comparator | Not described Receives: Drug: NG-monomethyl-L-arginine (L-NMMA) |
| Intravenous L-NMMA dose 3 | Active comparator | Not described Receives: Drug: NG-monomethyl-L-arginine (L-NMMA) |
| Intravenous L-NMMA dose 1 | Active comparator | Not described Receives: Drug: NG-monomethyl-L-arginine (L-NMMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured: 6 hours
Secondary outcomes (7)
GFR
Measured: 6 hours
Arterial Stiffness
Measured: 6 hours
Fractional excretion of sodium
Measured: 6 hours
Fractional excretion of potassium
Measured: 6 hours
Plasma renin concentration
Measured: 6 hour
Plasma angiotensin II
Measured: 6 hours
Plasma aldosterone
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Larsen, M.D., Principal investigator, Departments of Medical Research, Holstebro HospitalFrank H Christensen, M.D., Principal investigator, Departments of Medical Research, Holstebro HospitalErling B Pedersen, Dr.med., Principal investigator, Departments of Medical Research, Holstebro HospitalJesper N Bech, Ph.d., Principal investigator, Departments of Medical Research, Holstebro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070940
- Sponsor's protocol ID
- EBP.FHC.1.2009
- Other IDs
- 2009-017001-11, 2009
- Status last verified
- Feb 2011
- First submitted
- 17 Feb 2010
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-NMMA's Effect on Renal and Cardiovascular Variables in Healthy Subjects. A Randomized, Placebo-controlled Crossover Study.
- ClinicalTrials.gov ID
- NCT01070940
- Acronym / sponsor ID
- EBP.FHC.1.2009
- Conditions
- Healthy
- Keywords
- L-NMMA, blood pressure, arterial stiffness, pulse wave velocity, augmentation index, dose-response, healthy subjects, GFR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Isotonic saline infusion | Placebo comparator | Drug: Placebo |
| Intravenous L-NMMA dose 2 | Active comparator | Drug: NG-monomethyl-L-arginine (L-NMMA) |
| Intravenous L-NMMA dose 3 | Active comparator | Drug: NG-monomethyl-L-arginine (L-NMMA) |
| Intravenous L-NMMA dose 1 | Active comparator | Drug: NG-monomethyl-L-arginine (L-NMMA) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males
- Age 18-35 years
- BMI 18.5-30.0
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NG-monomethyl-L-arginine (L-NMMA)3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour | Drug | Intravenous L-NMMA dose 1 |
| NG-monomethyl-L-arginine (L-NMMA)6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour | Drug | Intravenous L-NMMA dose 3 |
| NG-monomethyl-L-arginine (L-NMMA)4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour | Drug | Intravenous L-NMMA dose 2 |
| PlaceboIsotonic saline solution IV priming dose + IV infusion for 1 hour | Drug | Isotonic saline infusion |
Primary outcome
Systolic blood pressure
Time frame: 6 hours
7 secondary outcomes
GFR
Time frame: 6 hours
Arterial Stiffness
Time frame: 6 hours
Fractional excretion of sodium
Time frame: 6 hours
Fractional excretion of potassium
Time frame: 6 hours
Plasma renin concentration
Time frame: 6 hour
Plasma angiotensin II
Time frame: 6 hours
Plasma aldosterone
Time frame: 6 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Larsen, M.D. principal investigator
Departments of Medical Research, Holstebro Hospital
Frank H Christensen, M.D. principal investigator
Departments of Medical Research, Holstebro Hospital
Erling B Pedersen, Dr.med. principal investigator
Departments of Medical Research, Holstebro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NG-monomethyl-L-arginine (L-NMMA) in people with Healthy, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011; AzTrials last refreshed its copy on 1 Nov 2026.