Enhancement of Postocclusive Reactive Hyperaemia by Dipyr... | NCT00268554

Studies
Enhancement of Postocclusive Reactive Hyperaemia by Dipyridamole

NCT00268554

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Mar 28, 2008Estimated

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Hyperemia
Hypoxia

Interventions

dipyridamole
caffeine

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

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Dec 21, 2005

First Submission Date that Met QC Criteria

Dec 21, 2005

First Posted Date

Dec 22, 2005Estimated

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

Mar 27, 2008

Last Update Posted Date

Mar 28, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether dipyridamole enhances postocclusive reactive hyperaemia by increasing extracellular adenosine concentrations during ischemia and reperfusion. Furthermore we hypothesize that dipyridamole augments postocclusive reactive hyperaemia by increasing adenosine receptor stimulation.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Measure	Description	Time Frame
forearm blood flow

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy volunteers between 18 and 50 years

Exclusion Criteria:

none specified

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerard Rongen, MD,PhD	Radboud University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud university Nijmegen Medical Centre		Nijmegen	Gelderland	6533 ZA	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006940	Hyperemia
D000860	Hypoxia

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004176	Dipyridamole
D002110	Caffeine

Ancestor Terms

ID	Term
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D014970	Xanthines

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
dipyridamole	Drug
caffeine	Drug