AtherosclerosisPhase 2NCT00120718
The Effect of Fasudil on Vascular Function in Humans
A Phase 2 study testing fasudil in people with Atherosclerosis and Hypercholesterolemia, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Hypercholesterolemia
- What is being tested?
- fasudil
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coronary artery disease
- Hyperlipidemia -OR-
- Healthy adults
Who cannot join
- 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
Show all 9Show fewer
- Chronic inflammatory disease
- Pregnancy
- Willing to withdraw statins for duration of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.
- Conditions
- Atherosclerosis, Hypercholesterolemia
- Being tested
- fasudil
- Medical subject headings
- Atherosclerosis, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fasudilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular reactivity
Secondary outcomes (5)
Rho kinase expression
Rho kinase activity
eNOS expression
eNOS activity
inflammatory markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2005 (estimated)
- Study startJun 2002
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mark A Creager, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120718
- Sponsor's protocol ID
- 2002-P-000890
- Status last verified
- Sep 2008
- First submitted
- 12 Jul 2005
- Last updated
- 30 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fasudil on Vascular Function in Humans
- ClinicalTrials.gov ID
- NCT00120718
- Acronym / sponsor ID
- 2002-P-000890
- Conditions
- Atherosclerosis, Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 19 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Coronary artery disease
- Hyperlipidemia -OR-
- Healthy adults
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fasudil | Drug | – |
Primary outcome
Vascular reactivity
5 secondary outcomes
Rho kinase expression
Rho kinase activity
eNOS expression
eNOS activity
inflammatory markers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Creager, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fasudil in people with Atherosclerosis and Hypercholesterolemia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular reactivity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2008.