NCT00120718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

September 30, 2008

Status Verified

September 1, 2008

Enrollment Period

4.6 years

First QC Date

July 12, 2005

Last Update Submit

September 26, 2008

Conditions

AtherosclerosisHypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Vascular reactivity

Secondary Outcomes (5)

  • Rho kinase expression

  • Rho kinase activity

  • eNOS expression

  • eNOS activity

  • inflammatory markers

Interventions

fasudilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

AtherosclerosisHypercholesterolemia

Interventions

fasudil

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mark A Creager, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 19, 2005

Study Start

June 1, 2002

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

September 30, 2008

Record last verified: 2008-09

Locations

US(1)