Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
NCT ID: NCT00783081
Last Updated: 2012-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
387 participants
INTERVENTIONAL
2008-11-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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low dose K-134
K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
mid dose K-134
K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
high dose K-134
K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Comparator
Cilostazol 100 mg BID
Cilostazol 100mg BID for 26 weeks.
Placebo
Placebo
Placebo BID for 26 weeks.
Interventions
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K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Cilostazol 100 mg BID
Cilostazol 100mg BID for 26 weeks.
Placebo
Placebo BID for 26 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Signs or symptoms of critical leg ischemia (CLI)
* Uncontrolled hypertension
* Tachycardia
* Poorly controlled diabetes
* Hypercholesterolemia
40 Years
ALL
No
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Roger Morgan, M.D., FACS
Role: STUDY_DIRECTOR
Kowa Research Institute, Inc.
Locations
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Tucson, Arizona, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Santa Rosa, California, United States
Vista, California, United States
Aurora, Colorado, United States
Clearwater, Florida, United States
Gulf Breeze, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Pensacola, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Aurora, Illinois, United States
Chicago, Illinois, United States
Hinsdale, Illinois, United States
Indianapolis, Indiana, United States
Auburn, Maine, United States
St Louis, Missouri, United States
Oklahoma City, Oklahoma, United States
Danville, Pennsylvania, United States
Warwick, Rhode Island, United States
Charleston, South Carolina, United States
Amarillo, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Gatchina, , Russia
Irkutsk, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Pskov, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Smolensk, , Russia
Sochi, , Russia
Tomsk, , Russia
Volgograd, , Russia
Yaroslavl, , Russia
Countries
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References
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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.
Other Identifiers
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K-134-2.01US
Identifier Type: -
Identifier Source: org_study_id
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