Heme Oxygenase (HO) Activity and Adenosine Induced Vasodi... | NCT00856817

Studies
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

NCT00856817

Sponsor

Radboud University Medical Center

Status

Terminated

Last Update Posted

Aug 11, 2011Estimated

Enrollment

6Estimated

Phase

Phase 4

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

L-arginine + heme arginate
Heme arginate + L-arginine

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment faillure. Similar study published by others. Not yet entered treatment phase.

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 5, 2009

First Submission Date that Met QC Criteria

Mar 5, 2009

First Posted Date

Mar 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2011

Last Update Posted Date

Aug 11, 2011Estimated

Name	Class
Dutch Diabetes Research Foundation	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
L-arginine + heme arginate	Drug	L-arginine first, heme arginate second three day treatment	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Centre		Nijmegen	Gelderland		Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001120	Arginine
C048849	heme arginate

Ancestor Terms

ID	Term
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino

Browse Leaves

Not provided

Browse Branches

Not provided