AtherosclerosisPhase 2NCT00851500
A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis
A Phase 2 study testing K-604 in people with Atherosclerosis, run by Kowa Research Institute, Inc. at 19 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment of atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- K-604
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 19 sitesUnited States
- Study dates
- Feb 2009to Aug 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate carotid artery stenosis
Who cannot join
- history of arteritis
- heavily calcified plaque
- uncontrolled hypertension
- poorly controlled diabetes
- hypercholesterolemia
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Buffalo, New York
Study site
Carrollton, Texas
Study site
Chandler, Arizona
Study site
Clearwater, Florida
Study site
Dallas, Texas
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Litchfield Park, Arizona
Study site
Los Angeles, California
Study site
Norfolk, Virginia
Study site
Oklahoma City, Oklahoma
Study site
Olympia, Washington
Study site
Phoenix, Arizona
Study site
Plano, Texas
Study site
Renton, Washington
Study site
San Diego, California
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Virginia Beach, Virginia
About this study
The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment of atherosclerosis.
- Conditions
- Atherosclerosis
- Being tested
- K-604, Placebo
- Keywords
- atherosclerosis, carotid artery disease
- Medical subject headings
- Atherosclerosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-604Drug
K-604 is given for 26 weeks
PlaceboOther
placebo tablets are given for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| low dose K-604 | Experimental | Not described Receives: Drug: K-604 |
| high dose K-604 | Experimental | Not described Receives: Drug: K-604 |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plaque composition over 6 months
Measured: 6 months
Secondary outcomes (1)
Change from baseline in plaque size over 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2011
- Study completionAug 2011
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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851500
- Sponsor's protocol ID
- K-604-2.01US
- Status last verified
- Aug 2011
- First submitted
- 24 Feb 2009
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis
- ClinicalTrials.gov ID
- NCT00851500
- Acronym / sponsor ID
- K-604-2.01US
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, carotid artery disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Feb 2009 (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 this study is to evaluate the safety and efficacy of K-604 for the treatment of atherosclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose K-604 | Experimental | Drug: K-604 |
| high dose K-604 | Experimental | Drug: K-604 |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- moderate carotid artery stenosis
Key exclusion criteria (5 listed)
- history of arteritis
- heavily calcified plaque
- uncontrolled hypertension
- poorly controlled diabetes
- hypercholesterolemia
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 |
|---|---|---|
| K-604K-604 is given for 26 weeks | Drug | high dose K-604, low dose K-604 |
| Placeboplacebo tablets are given for 26 weeks | Other | placebo |
Primary outcome
Change from baseline in plaque composition over 6 months
Time frame: 6 months
1 secondary outcome
Change from baseline in plaque size over 6 months.
Time frame: 6 months
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 17 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-604 in people with Atherosclerosis, run by Kowa Research Institute, Inc. at 19 sites 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 1 inclusion and 5 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 17 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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. Some participants in this study may receive a placebo. 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?
Change from baseline in plaque composition over 6 months (time frame: 6 months). 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 17 Aug 2011.