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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783081
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 22, 2012
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
Intermittent Claudication Drug: K-134 Drug: Cilostazol 100 mg BID Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

Arm Intervention/treatment
Experimental: low dose K-134 Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.

Experimental: mid dose K-134 Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.

Experimental: high dose K-134 Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.

Active Comparator: Comparator Drug: Cilostazol 100 mg BID
Cilostazol 100mg BID for 26 weeks.

Placebo Comparator: Placebo Drug: Placebo
Placebo BID for 26 weeks.

Primary Outcome Measures :
  1. Improvement in peak walking time at 26 weeks [ Time Frame: 26 Weeks ]

Secondary Outcome Measures :
  1. Improvement in claudication onset time at 26 weeks [ Time Frame: 26 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00783081

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United States, Arizona
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Beverly Hills, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Santa Rosa, California, United States
Vista, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Florida
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
United States, Illinois
Aurora, Illinois, United States
Chicago, Illinois, United States
Hinsdale, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Maine
Auburn, Maine, United States
United States, Missouri
St Louis, Missouri, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Danville, Pennsylvania, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Amarillo, Texas, United States
Houston, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Russian Federation
Gatchina, Russian Federation
Irkutsk, Russian Federation
Moscow, Russian Federation
Novosibirsk, Russian Federation
Pskov, Russian Federation
Saint-Petersburg, Russian Federation
Saratov, Russian Federation
Smolensk, Russian Federation
Sochi, Russian Federation
Tomsk, Russian Federation
Volgograd, Russian Federation
Yaroslavl, Russian Federation
Sponsors and Collaborators
Kowa Research Institute, Inc.
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Study Director: Roger Morgan, M.D., FACS Kowa Research Institute, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kowa Research Institute, Inc. Identifier: NCT00783081    
Other Study ID Numbers: K-134-2.01US
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012
Keywords provided by Kowa Research Institute, Inc.:
Intermittent Claudication
Peripheral Arterial Disease
Additional relevant MeSH terms:
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Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors