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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014