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CompletedNCT00120718Updated Sep 30, 2008

The Effect of Fasudil on Vascular Function in Humans

A Phase 2 interventional study of fasudil in Atherosclerosis and Hypercholesterolemia, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-09-30.

Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.

02

Conditions studied

  • Atherosclerosis
  • Hypercholesterolemia
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's planned enrollment of 60 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Coronary artery disease
  • Hyperlipidemia -OR-
  • Healthy adults

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
60 participants (estimated)

Interventions

  • Drugfasudil
06

What researchers measure

Primary outcomes

  1. Vascular reactivity

Secondary outcomes

  1. Rho kinase expression

  2. Rho kinase activity

  3. eNOS expression

  4. eNOS activity

  5. inflammatory markers

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00120718
Lead sponsor
Brigham and Women's Hospital
First posted
Jul 19, 2005
Start date
Jun 2002
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Sep 30, 2008

Study contacts

Mark A Creager, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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