Benfotiamine Prevents Vascular Dysfunction in Healthy Smo... | NCT00785460

Studies
Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

NCT00785460

Sponsor

Ruhr University of Bochum

Status

Completed

Last Update Posted

Nov 5, 2008Estimated

Enrollment

20Actual

Phase

Phase 3

Conditions

Healthy Subjects

Interventions

Benfotiamine

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

Nov 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

Jan 2008

Primary Completion Date

May 2008

Completion Date

Not provided

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 4, 2008

First Posted Date

Nov 5, 2008Estimated

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

Nov 4, 2008

Last Update Posted Date

Nov 5, 2008Estimated

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

Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation of the brachial artery.

Detailed Description

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benfotiamine and Smoking	Experimental		Drug: Benfotiamine
Smoking alone	Placebo Comparator		Drug: Benfotiamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Benfotiamine	Drug		Benfotiamine and Smoking Smoking alone

Measure	Description	Time Frame
Flow mediated dilatation		3 days

Measure	Description	Time Frame
Laboratory markers of endothelial function		3 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy habitual smokers

Exclusion Criteria:

any kind of chronic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alin Stirban, MD	Ruhr-University Bochum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart and Diabetes Center		Bad Oeynhausen	North Rhine-Westphalia	32545	Germany

Intervention Browse Module

MeSH Terms

ID	Term
C013835	benphothiamine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided