Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

NCT00856817 | Terminated Phase 4

• 1 other identifier: HOADO
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Adenosine induced vasodilation

  following a three day treatment with either heme arginate or L arginine

Secondary Outcomes (1)

• heme oxygenase expression and activity

  assessed during and following a three day treatment with either heme arginate or L-arginine

Study Arms (2)

1

EXPERIMENTAL

L-arginine treatment first, heme arginate treatment second

Drug: L-arginine + heme arginate

2

EXPERIMENTAL

Heme arginate treatment first, L-arginine treatment second

Drug: Heme arginate + L-arginine

Interventions

L-arginine + heme arginate DRUG

L-arginine first, heme arginate second three day treatment

1

Heme arginate + L-arginine DRUG

Heme arginate first, L-arginine second three day treatment

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Diabetes Research Foundation: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Arginine; heme arginate

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: March 1, 2009
• Last Updated: August 11, 2011

Record last verified: 2010-01

Locations

NL (1)