The Effect of Fasudil on Vascular Function in Humans

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00120718
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 55
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Hypercholesterolemia	Drug: fasudil	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Effect of Fasudil on Vascular Function in Humans
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

1. Vascular reactivity []

Secondary Outcome Measures

1. Rho kinase expression []

2. Rho kinase activity []

3. eNOS expression []

4. eNOS activity []

5. inflammatory markers []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00120718
• Other Study ID Numbers: 2002-P-000890
• First Posted: Jul 19, 2005
• Last Update Posted: Sep 30, 2008
• Last Verified: Sep 1, 2008

• Additional relevant MeSH terms: Atherosclerosis; Hypercholesterolemia; Fasudil

Study Results

No Results Posted as of Sep 30, 2008