Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856817

Enrollment

Registered

2009-03-06

Start date

2009-03-31

Completion date

Unknown

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease

Brief 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.

Interventions

DRUGL-arginine + heme arginate

L-arginine first, heme arginate second three day treatment

DRUGHeme arginate + L-arginine

Heme arginate first, L-arginine second three day treatment

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Adenosine induced vasodilation	following a three day treatment with either heme arginate or L arginine

Secondary

Measure	Time frame
heme oxygenase expression and activity	assessed during and following a three day treatment with either heme arginate or L-arginine

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026