Clinical trial NCT00783081: Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intermittent Claudication
Keywords: Intermittent Claudication
Peripheral Arterial Disease
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 387
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.


Eligibility criteria: Inclusion Criteria:

- Stable claudication symptoms

Exclusion Criteria:

* Lower extremity amputation
* Signs or symptoms of critical leg ischemia (CLI)
* Uncontrolled hypertension
* Tachycardia
* Poorly controlled diabetes
* Hypercholesterolemia

Primary outcomes:
measure: Improvement in peak walking time at 26 weeks
timeFrame: 26 Weeks
Secondary outcomes:
measure: Improvement in claudication onset time at 26 weeks
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Vista
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Gulf Breeze
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Aurora
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Hinsdale
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Auburn
country: United States
state: Maine
city: St Louis
country: United States
state: Missouri
city: Oklahoma City
country: United States
state: Oklahoma
city: Danville
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Amarillo
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Gatchina
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Pskov
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Sochi
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Roger Morgan, M.D., FACS
role: STUDY_DIRECTOR
References:
citation: 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.