Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
Information source: Radboud University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atherosclerotic Cardiovascular Disease
Intervention: L-arginine + heme arginate (Drug); Heme arginate + L-arginine (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Radboud University Overall contact:
Dekker, MD, Email: d.dekker@aig.umcn.nl
Summary
The purpuse 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.
Clinical Details
Study design: Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Adenosine induced vasodilation
Secondary outcome: heme oxygenase expression and activity
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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 heamatology 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
Locations and Contacts
Dekker, MD, Email: d.dekker@aig.umcn.nl
Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, Netherlands
Additional Information
Starting date: March 2009
Last updated: March 5, 2009
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