The Effect of Fasudil on Vascular Function in Humans

September 26, 2008 updated by: Brigham and Women's Hospital
The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Vascular reactivity

Secondary Outcome Measures

Outcome Measure
Rho kinase expression
Rho kinase activity
eNOS expression
eNOS activity
inflammatory markers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

July 12, 2005

First Submitted That Met QC Criteria

July 18, 2005

First Posted (Estimate)

July 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 30, 2008

Last Update Submitted That Met QC Criteria

September 26, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002-P-000890

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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