Healthy SubjectsNCT00180063
Characterization of Local Vascular Effects of LNMMA
A study testing L-NMMA(drug) in people with Healthy Subjects, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human hand veins. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- L-NMMA(drug)
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Oct 2003to Sep 2005
- Phase
- Interventional
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
Who cannot join
- any relevant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Clinical Pharmacology, Medical Faculty, University of Technology
Dresden, 01307
About this study
Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human hand veins.
- Conditions
- Healthy Subjects
- Being tested
- L-NMMA(drug)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-NMMA(drug)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Wilhelm Kirch, MD, Study chair, Institute of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180063
- Sponsor's protocol ID
- IKPD 01-02 Amend LNMMA
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 2 Nov 2005
- Results posted
- No
Publications
Schindler C, Leuschner S, Schwanebeck U, Kirch W. Characterization of local vascular effects of the nitric oxide inhibitor NG-monomethyl-L-arginine on dorsal hand veins. J Clin Pharmacol. 2012 Jun;52(6):859-69. doi: 10.1177/0091270011406277. Epub 2011 May 12.
PubMed 21566204
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Local Vascular Effects of LNMMA
- ClinicalTrials.gov ID
- NCT00180063
- Acronym / sponsor ID
- IKPD 01-02 Amend LNMMA
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Sep 2005
- First posted
- 16 Sep 2005 (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.
Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human hand veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (1 listed)
- any relevant disease
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 |
|---|---|---|
| L-NMMA(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 2 Nov 2005.
- Derived from this study: PubMed 21566204Schindler C, Leuschner S, Schwanebeck U, Kirch W. Characterization of local vascular effects of the nitric oxide inhibitor NG-monomethyl-L-arginine on dorsal hand veins. J Clin Pharmacol. 2012 Jun;52(6):859-69. doi: 10.1177/0091270011406277. Epub 2011 May 12.
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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.
Wilhelm Kirch, MD study chair
Institute of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-NMMA(drug) in people with Healthy Subjects, run by Technische Universität Dresden at 1 site in Germany.
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 1 inclusion and 1 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 2 Nov 2005. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
On the ClinicalTrials.gov record for NCT00180063, which also lists 1 linked publication.
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 2 Nov 2005.