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The Effect of Fasudil on Vascular Function in Humans

NCT ID: NCT00120718

Last Updated: 2008-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2007-01-31

Brief Summary

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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

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Conditions

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Atherosclerosis Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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fasudil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brigham and Women's Hospital

Principal Investigators

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Mark A Creager, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2002-P-000890

Identifier Type: -

Identifier Source: org_study_id