Atherosclerosis |
Arteriosclerosis; Arteriosclerosis/Atherosclerosis |
Clinical Trial: The Effect of Fasudil On Vascular Function in Humans
This study is currently recruiting patients.
|
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 II |
MedlinePlus related topics: Cholesterol; Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: Vascular reactivity
Secondary Outcomes: Rho kinase expression; Rho kinase activity; eNOS expression; eNOS activity; inflammatory markers
Expected Total Enrollment: 60
Secondary Outcomes: Rho kinase expression; Rho kinase activity; eNOS expression; eNOS activity; inflammatory markers
Expected Total Enrollment: 60
Study start: June 2002
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00120718
Anju Nohria, MD 617-525-6852 anohria@partners.org
Jeanne E. Doyle, RN 617-525-7055 jdoyle7@partners.org
Jeanne E. Doyle, RN 617-525-7055 jdoyle7@partners.org
Massachusetts
Brigham and Women''''s Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Anju Nohria, MD 617-525-6852 anohria@partners.org
Jeanne E Doyle, RN 617-525-7055 jdoyle7@partners.org
Mark A Creager, MD, Principal Investigator
Jeanne E Doyle, RN 617-525-7055 jdoyle7@partners.org
Mark A Creager, MD, Principal Investigator
Study chairs or principal investigators
Mark A Creager, MD, Principal Investigator, Brigham and Women''''s Hospital
More Information
Study ID Numbers: 2002-P-000890
Record last reviewed: March 2005
Last Updated: July 25, 2005
Record first received: July 18, 2005
ClinicalTrials.gov Identifier: NCT00120718
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: March 2005
Last Updated: July 25, 2005
Record first received: July 18, 2005
ClinicalTrials.gov Identifier: NCT00120718
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26

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