The Effect of Fasudil on Vascular Function in Humans | NCT00120718

Studies
The Effect of Fasudil on Vascular Function in Humans

NCT00120718

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Sep 30, 2008Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Atherosclerosis
Hypercholesterolemia

Interventions

fasudil

Countries

United States

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

Sep 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

Jun 2002

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 2007Actual

First Submitted Date

Jul 12, 2005

First Submission Date that Met QC Criteria

Jul 18, 2005

First Posted Date

Jul 19, 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

Sep 26, 2008

Last Update Posted Date

Sep 30, 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 the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
fasudil	Drug

Measure	Description	Time Frame
Vascular reactivity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Coronary artery disease
Hyperlipidemia -OR-
Healthy adults

Exclusion Criteria:

Unstable angina, myocardial infarction or revascularization within 3 months
Symptomatic heart failure
Creatinine > 3.0 mg/dl
Liver enzymes > 3X upper limit of normal
Chronic hypoxia
Significant anemia
Chronic inflammatory disease
Pregnancy
Willing to withdraw statins for duration of study

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark A Creager, MD	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis
D006937	Hypercholesterolemia

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
C049347	fasudil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Rho kinase expression
Rho kinase activity
eNOS expression