Atherosclerotic Cardiovascular DiseasePhase 4NCT00856817
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
A Phase 4 study testing L-arginine + heme arginate and Heme arginate + L-arginine in people with Atherosclerotic Cardiovascular Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- L-arginine + heme arginate and Heme arginate + L-arginine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to not given
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 and no older than 65 on the day of first dosing
- healthy
- Quetelet Index (Body Mass Index) of 18 to 30 kg/m2
- In general, results of haematology and chemistry should be within the laboratory's reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range.
Who cannot join
- Documented history of sensitivity / idiosyncrasy to medicinal products or excipients
- history of smoking within the past year
- history of or current abuse of drugs, alcohol and/or solvents
- Current use of any (over the counter) medication potentially influencing heme oxygenase or the cardiovascular system
- Inability to understand the nature and extent of the trial and the procedures required
- Participation to a drug trial within 60 days prior to the first dose
- Febrile illness within 3 days before the first dose
- Heterozygosity (LS) or homozygosity (LL) with regard to the number of GT repeats in the HO-1 promoter region
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland
About this study
The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- L-arginine + heme arginate, Heme arginate + L-arginine
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginine + heme arginateDrug
L-arginine first, heme arginate second three day treatment
Heme arginate + L-arginineDrug
Heme arginate first, L-arginine second three day treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | L-arginine treatment first, heme arginate treatment second Receives: Drug: L-arginine + heme arginate |
| 2 | Experimental | Heme arginate treatment first, L-arginine treatment second Receives: Drug: Heme arginate + L-arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenosine induced vasodilation
Measured: following a three day treatment with either heme arginate or L arginine
Secondary outcomes (1)
heme oxygenase expression and activity
Measured: assessed during and following a three day treatment with either heme arginate or L-arginine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
Why it stopped: Recruitment faillure. Similar study published by others. Not yet entered treatment phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856817
- Sponsor's protocol ID
- HOADO
- Status last verified
- Jan 2010
- First submitted
- 5 Mar 2009
- Last updated
- 11 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
- ClinicalTrials.gov ID
- NCT00856817
- Acronym / sponsor ID
- HOADO
- Conditions
- Atherosclerotic Cardiovascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment faillure. Similar study published by others. Not yet entered treatment phase.
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Study start
- Mar 2009
- First posted
- 6 Mar 2009 (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 determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: L-arginine + heme arginateL-arginine treatment first, heme arginate treatment second |
| 2 | Experimental | Drug: Heme arginate + L-arginineHeme arginate treatment first, L-arginine treatment second |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 and no older than 65 on the day of first dosing
- healthy
- Quetelet Index (Body Mass Index) of 18 to 30 kg/m2
- In general, results of haematology and chemistry should be within the laboratory's reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range.
Key exclusion criteria (8 listed)
- Documented history of sensitivity / idiosyncrasy to medicinal products or excipients
- history of smoking within the past year
- history of or current abuse of drugs, alcohol and/or solvents
- Current use of any (over the counter) medication potentially influencing heme oxygenase or the cardiovascular system
- Inability to understand the nature and extent of the trial and the procedures required
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-arginine + heme arginateL-arginine first, heme arginate second three day treatment | Drug | 1 |
| Heme arginate + L-arginineHeme arginate first, L-arginine second three day treatment | Drug | 2 |
Primary outcome
Adenosine induced vasodilation
Time frame: following a three day treatment with either heme arginate or L arginine
1 secondary outcome
heme oxygenase expression and activity
Time frame: assessed during and following a three day treatment with either heme arginate or L-arginine
Results and safety
The study was stopped early (reason given: Recruitment faillure. Similar study published by others. Not yet entered treatment phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-arginine + heme arginate and Heme arginate + L-arginine in people with Atherosclerotic Cardiovascular Disease, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Aug 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Recruitment faillure. Similar study published by others. Not yet entered treatment phase.). Results are not available in the source record.
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?
Adenosine induced vasodilation (time frame: following a three day treatment with either heme arginate or L arginine). 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 11 Aug 2011.