HypertensionPhase 1NCT00345150
Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls
A Phase 1 study testing Ng-monomethyl-L-arginine (drug) in people with Hypertension, run by Regional Hospital Holstebro.
Trial summary
The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Ng-monomethyl-L-arginine (drug)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Essential hypertension (blood pressure > 140/90) with no signs of secondary hypertension
- P-creatinine < 200 µmol/L
Who cannot join
- Anamnestic or clinical signs of heart disease, renal disease, liver disease, neoplastic disease, anemia or cerebro-vascular insult
- Medication except antihypertensives
- Drug or alcohol abuse
- Pregnancy
About this study
Official title: Phase 1 Study of the Effects of Systemic Nitric Oxide Inhibition With Ng-Monomethyl-L-Arginine on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls
The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. The results are compared with a group of healthy subjects.
Read the detailed description
The study investigates the effects of Ng-monomethyl-L-arginine (L-NMMA) on:
- renal hemodynamics (renal plasma flow and glomerular filtration rate)
- renal sodium excretion
- lithium clearance and fractional lithium excretion
- plasma levels of vasoactive hormones
- blood pressure and heart rate
- Conditions
- Hypertension
- Being tested
- Ng-monomethyl-L-arginine (drug)
- Keywords
- hypertension, nitric oxide, renal hemodynamics
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ng-monomethyl-L-arginine (drug)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Jesper N Bech, MD, Ph.D., Principal investigator, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, DenmarkErling B Pedersen, Professor, Study chair, Holstebro Hospital, 7500 Holstebro, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345150
- Sponsor's protocol ID
- MED.RES.HOS.1995.01.JNB
- Status last verified
- Jun 2006
- First submitted
- 24 Jun 2006
- Last updated
- 27 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Effects of Systemic Nitric Oxide Inhibition With Ng-Monomethyl-L-Arginine on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls
- ClinicalTrials.gov ID
- NCT00345150
- Acronym / sponsor ID
- MED.RES.HOS.1995.01.JNB
- Conditions
- Hypertension
- Keywords
- hypertension, nitric oxide, renal hemodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- First posted
- 27 Jun 2006 (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 study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. The results are compared with a group of healthy subjects.
Detailed description
The study investigates the effects of Ng-monomethyl-L-arginine (L-NMMA) on:
- renal hemodynamics (renal plasma flow and glomerular filtration rate)
- renal sodium excretion
- lithium clearance and fractional lithium excretion
- plasma levels of vasoactive hormones
- blood pressure and heart rate
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Essential hypertension (blood pressure > 140/90) with no signs of secondary hypertension
- P-creatinine < 200 µmol/L
Key exclusion criteria (4 listed)
- Anamnestic or clinical signs of heart disease, renal disease, liver disease, neoplastic disease, anemia or cerebro-vascular insult
- Medication except antihypertensives
- Drug or alcohol abuse
- Pregnancy
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 (drug) | Drug | – |
Primary outcome
Not reported in the source record.
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 27 Jun 2006.
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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.
Jesper N Bech, MD, Ph.D. principal investigator
Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Erling B Pedersen, Professor study chair
Holstebro Hospital, 7500 Holstebro, Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ng-monomethyl-L-arginine (drug) in people with Hypertension, run by Regional Hospital Holstebro.
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 2 inclusion and 4 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 27 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
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 27 Jun 2006.