Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
1 other identifier
interventional
387
2 countries
42
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
42 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
First Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMarch 22, 2012
March 1, 2012
1.7 years
October 30, 2008
March 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in peak walking time at 26 weeks
26 Weeks
Secondary Outcomes (1)
Improvement in claudication onset time at 26 weeks
26 Weeks
Study Arms (5)
low dose K-134
EXPERIMENTALmid dose K-134
EXPERIMENTALhigh dose K-134
EXPERIMENTALComparator
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Eligibility Criteria
You may qualify if:
- \- Stable claudication symptoms
You may not qualify if:
- Lower extremity amputation
- Signs or symptoms of critical leg ischemia (CLI)
- Uncontrolled hypertension
- Tachycardia
- Poorly controlled diabetes
- Hypercholesterolemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Santa Rosa, California, United States
Unknown Facility
Vista, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Gulf Breeze, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Pensacola, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Aurora, Illinois, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Hinsdale, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Auburn, Maine, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Danville, Pennsylvania, United States
Unknown Facility
Warwick, Rhode Island, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Amarillo, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Madison, Wisconsin, United States
Unknown Facility
Gatchina, Russia
Unknown Facility
Irkutsk, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Pskov, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Saratov, Russia
Unknown Facility
Smolensk, Russia
Unknown Facility
Sochi, Russia
Unknown Facility
Tomsk, Russia
Unknown Facility
Volgograd, Russia
Unknown Facility
Yaroslavl, Russia
Related Publications (1)
Lewis RJ, Connor JT, Teerlink JR, Murphy JR, Cooper LT, Hiatt WR, Brass EP. Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication. Trials. 2011 May 25;12:134. doi: 10.1186/1745-6215-12-134.
PMID: 21612611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roger Morgan, M.D., FACS
Kowa Research Institute, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
November 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
March 22, 2012
Record last verified: 2012-03