Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

NCT ID: NCT00856817

Last Updated: 2011-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerotic Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

L-arginine treatment first, heme arginate treatment second

Group Type EXPERIMENTAL

L-arginine + heme arginate

Intervention Type DRUG

L-arginine first, heme arginate second three day treatment

2

Heme arginate treatment first, L-arginine treatment second

Group Type EXPERIMENTAL

Heme arginate + L-arginine

Intervention Type DRUG

Heme arginate first, L-arginine second three day treatment

Interventions

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L-arginine + heme arginate

L-arginine first, heme arginate second three day treatment

Intervention Type DRUG

Heme arginate + L-arginine

Heme arginate first, L-arginine second three day treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dutch Diabetes Research Foundation

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Radboud University Nijmegen Medical Centre

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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HOADO

Identifier Type: -

Identifier Source: org_study_id

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