The Effect of Fasudil on Vascular Function in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120718
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : September 30, 2008
Information provided by:
Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Hypercholesterolemia Drug: fasudil Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Fasudil on Vascular Function in Humans
Study Start Date : June 2002
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Primary Outcome Measures :
  1. Vascular reactivity

Secondary Outcome Measures :
  1. Rho kinase expression
  2. Rho kinase activity
  3. eNOS expression
  4. eNOS activity
  5. inflammatory markers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120718

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Mark A Creager, MD Brigham and Women's Hospital

Responsible Party: Mark A. Creager, MD, Brigham and Women's Hospital Identifier: NCT00120718     History of Changes
Other Study ID Numbers: 2002-P-000890
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protein Kinase Inhibitors
Enzyme Inhibitors