Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication

Condition(s) targeted: Intermittent Claudication

Intervention: K-134 (Drug); Cilostazol 100 mg BID (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Kowa Research Institute, Inc.

Official(s) and/or principal investigator(s):
Roger Morgan, M.D., FACS, Study Director, Affiliation: Kowa Research Institute, Inc.

Overall contact:
Colorado Prevention Center, Phone: 303-860-9900

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Improvement in peak walking time at 26 weeks

Secondary outcome: Improvement in claudication onset time at 26 weeks

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Colorado Prevention Center, Phone: 303-860-9900

Saint-Petersburg, Russian Federation; Recruiting

Gatchina, Russian Federation; Recruiting

Pskov, Russian Federation; Recruiting

Moscow, Russian Federation; Recruiting

Yaroslavl, Russian Federation; Recruiting

Smolensk, Russian Federation; Recruiting

Saratov, Russian Federation; Recruiting

Volgograd, Russian Federation; Recruiting

Sochi, Russian Federation; Recruiting

Novosibirsk, Russian Federation; Recruiting

Tomsk, Russian Federation; Recruiting

Irkutsk, Russian Federation; Recruiting

Tucson, Arizona, United States; Recruiting

Little Rock, Arkansas, United States; Not yet recruiting

Beverly Hills, California, United States; Recruiting

Santa Rosa, California, United States; Recruiting

Vista, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Sacramento, California, United States; Recruiting

Aurora, Colorado, United States; Recruiting

Hialeah, Florida, United States; Not yet recruiting

Clearwater, Florida, United States; Recruiting

Jacksonville, Florida, United States; Recruiting

Sarasota, Florida, United States; Recruiting

Pensacola, Florida, United States; Not yet recruiting

Gulf Breeze, Florida, United States; Recruiting

St. Petersburg, Florida, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Hinsdale, Illinois, United States; Recruiting

Aurora, Illinois, United States; Recruiting

Indianapolis, Indiana, United States; Recruiting

Auburn, Maine, United States; Recruiting

St Louis, Missouri, United States; Recruiting

Oklahoma City, Oklahoma, United States; Not yet recruiting

Danville, Pennsylvania, United States; Recruiting

Warwick, Rhode Island, United States; Recruiting

Charleston, South Carolina, United States; Recruiting

Houston, Texas, United States; Recruiting

Amarillo, Texas, United States; Not yet recruiting

Richmond, Virginia, United States; Recruiting

Norfolk, Virginia, United States; Recruiting

Madison, Wisconsin, United States; Recruiting

Starting date: November 2008
Last updated: July 6, 2009