The Effect of Fasudil on Vascular Function in Humans

This study has been completed.
Information provided by:
Brigham and Women's Hospital Identifier:
First received: July 12, 2005
Last updated: September 26, 2008
Last verified: September 2008
The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.

Condition Intervention Phase
Drug: fasudil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Fasudil on Vascular Function in Humans

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Vascular reactivity

Secondary Outcome Measures:
  • Rho kinase expression
  • Rho kinase activity
  • eNOS expression
  • eNOS activity
  • inflammatory markers

Estimated Enrollment: 60
Study Start Date: June 2002
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Mark A. Creager, MD, Brigham and Women's Hospital Identifier: NCT00120718     History of Changes
Other Study ID Numbers: 2002-P-000890 
Study First Received: July 12, 2005
Last Updated: September 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Vasodilator Agents processed this record on May 25, 2016