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NCT00120718 Clinical Trial

The Effect of Fasudil on Vascular Function in Humans

Atherosclerosis Clinical Trial

Official title:
The Effect of Fasudil on Vascular Function in Humans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00120718
Other study ID # 2002-P-000890
Secondary ID
Status Completed
Phase Phase 2
First received July 12, 2005
Last updated September 26, 2008
Start date June 2002
Est. completion date January 2007

Study information
Verified date September 2008
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• fasudil

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vascular reactivity
Secondary Rho kinase expression
Secondary Rho kinase activity
Secondary eNOS expression
Secondary eNOS activity
Secondary inflammatory markers
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