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The Effect of Fasudil on Vascular Function in Humans

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00120718
First received: July 12, 2005
Last updated: September 26, 2008
Last verified: September 2008
  Purpose

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
Atherosclerosis
Hypercholesterolemia
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120718

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

No publications provided

Responsible Party: Mark A. Creager, MD, Brigham and Women's Hospital
ClinicalTrials.gov 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:
Arteriosclerosis
Atherosclerosis
Hypercholesterolemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Fasudil
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014