Pharmacokinetics of Pavaverine After Intraluminal Adminis... | NCT01436981

Studies
Pharmacokinetics of Pavaverine After Intraluminal Administration

NCT01436981

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Jun 4, 2013Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Injury of Internal Mammary Artery
Complications Due to Coronary Artery Bypass Graft

Interventions

CABG

Countries

Germany

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

Jun 2013

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

Oct 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Sep 14, 2011

First Submission Date that Met QC Criteria

Sep 19, 2011

First Posted Date

Sep 20, 2011Estimated

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

Jun 3, 2013

Last Update Posted Date

Jun 4, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Name	Class
Klinikum Ludwigshafen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 the pharmacokinetic of papaverine after administration into the artery mammaria interna.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CABG with papaverine		Patients with CABG procedure	Procedure: CABG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CABG	Procedure	Preparation of artery mammaria interna	CABG with papaverine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum plasma concentration of papaverine	Serum probes will be analysed for the concentrations of papaverine.	4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CABG
Administration of papaverine into mammaria interna

Exclusion Criteria:

Allergy against papaverine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

CABG patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arndt H Kiessling, MD	Johann Wolfgang Goethe University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Goethe Universität Frankfurt		Frankfurt am Main	Hesse	60590	Germany