Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

This study has been terminated.
(Recruitment faillure. Similar study published by others. Not yet entered treatment phase.)
Sponsor:
Collaborator:
Dutch Diabetes Research Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00856817
First received: March 5, 2009
Last updated: August 10, 2011
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Atherosclerotic Cardiovascular Disease
Drug: L-arginine + heme arginate
Drug: Heme arginate + L-arginine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Adenosine induced vasodilation [ Time Frame: following a three day treatment with either heme arginate or L arginine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • heme oxygenase expression and activity [ Time Frame: assessed during and following a three day treatment with either heme arginate or L-arginine ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: March 2009
Arms Assigned Interventions
Experimental: 1
L-arginine treatment first, heme arginate treatment second
Drug: L-arginine + heme arginate
L-arginine first, heme arginate second three day treatment
Experimental: 2
Heme arginate treatment first, L-arginine treatment second
Drug: Heme arginate + L-arginine
Heme arginate first, L-arginine second three day treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856817

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University
Dutch Diabetes Research Foundation
  More Information

No publications provided

Responsible Party: P. Smits, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00856817     History of Changes
Other Study ID Numbers: HOADO
Study First Received: March 5, 2009
Last Updated: August 10, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014