- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00856817
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
August 10, 2011 updated by: Radboud University Medical Center
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
6
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands
- Radboud University Nijmegen Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
L-arginine treatment first, heme arginate treatment second
|
L-arginine first, heme arginate second three day treatment
|
Experimental: 2
Heme arginate treatment first, L-arginine treatment second
|
Heme arginate first, L-arginine second three day treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adenosine induced vasodilation
Time Frame: following a three day treatment with either heme arginate or L arginine
|
following a three day treatment with either heme arginate or L arginine
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
heme oxygenase expression and activity
Time Frame: assessed during and following a three day treatment with either heme arginate or L-arginine
|
assessed during and following a three day treatment with either heme arginate or L-arginine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Study Registration Dates
First Submitted
March 5, 2009
First Submitted That Met QC Criteria
March 5, 2009
First Posted (Estimate)
March 6, 2009
Study Record Updates
Last Update Posted (Estimate)
August 11, 2011
Last Update Submitted That Met QC Criteria
August 10, 2011
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOADO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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