A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis
1 other identifier
interventional
210
1 country
19
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment of atherosclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
19 active sites
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
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 17, 2011
August 1, 2011
2.3 years
February 24, 2009
August 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in plaque composition over 6 months
6 months
Secondary Outcomes (1)
Change from baseline in plaque size over 6 months.
6 months
Study Arms (3)
low dose K-604
EXPERIMENTALhigh dose K-604
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- moderate carotid artery stenosis
You may not qualify if:
- history of arteritis
- heavily calcified plaque
- uncontrolled hypertension
- poorly controlled diabetes
- hypercholesterolemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Chandler, Arizona, United States
Unknown Facility
Litchfield Park, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Carrollton, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Virginia Beach, Virginia, United States
Unknown Facility
Olympia, Washington, United States
Unknown Facility
Renton, Washington, United States
Unknown Facility
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2009
First Posted
February 26, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2011
Study Completion
August 1, 2011
Last Updated
August 17, 2011
Record last verified: 2011-08