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

This study is currently recruiting participants.

Verified by Kowa Research Institute, Inc., February 2009

First Received: October 30, 2008 Last Updated: February 11, 2009 History of Changes

Sponsored by:	Kowa Research Institute, Inc.
Information provided by:	Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:	NCT00783081

Purpose

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

Condition	Intervention	Phase
Intermittent Claudication	Drug: K-134 Drug: Cilostazol 100 mg BID Drug: Placebo	Phase II

Drug Information available for: Cilostazol

U.S. FDA Resources

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

Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:

Improvement in peak walking time at 26 weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in claudication onset time at 26 weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	370
Study Start Date:	November 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
low dose K-134: Experimental	Drug: K-134 K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
mid dose K-134: Experimental	Drug: K-134 K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
high dose K-134: Experimental	Drug: K-134 K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Comparator: Active Comparator	Drug: Cilostazol 100 mg BID Cilostazol 100mg BID for 26 weeks.
Placebo: Placebo Comparator	Drug: Placebo Placebo BID for 26 weeks.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783081

Contacts

Contact: Colorado Prevention Center

303-860-9900

Locations

United States, Arkansas
	Not yet recruiting
Little Rock, Arkansas, United States
United States, California
	Recruiting
Beverly Hills, California, United States
	Recruiting
Santa Rosa, California, United States
	Recruiting
Vista, California, United States
	Not yet recruiting
Los Angeles, California, United States
	Recruiting
Sacramento, California, United States
United States, Colorado
	Recruiting
Aurora, Colorado, United States
United States, Florida
	Not yet recruiting
Hialeah, Florida, United States
	Recruiting
Clearwater, Florida, United States
	Recruiting
Jacksonville, Florida, United States
	Not yet recruiting
Sarasota, Florida, United States
	Not yet recruiting
Pensacola, Florida, United States
United States, Illinois
	Not yet recruiting
Chicago, Illinois, United States
United States, Indiana
	Recruiting
Indianapolis, Indiana, United States
United States, Maine
	Recruiting
Auburn, Maine, United States
United States, Missouri
	Not yet recruiting
St Louis, Missouri, United States
United States, Oklahoma
	Not yet recruiting
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
	Not yet recruiting
Danville, Pennsylvania, United States
United States, Rhode Island
	Recruiting
Warwick, Rhode Island, United States
United States, Texas
	Not yet recruiting
Houston, Texas, United States
	Not yet recruiting
Amarillo, Texas, United States
United States, Virginia
	Recruiting
Richmond, Virginia, United States
	Recruiting
Norfolk, Virginia, United States

Sponsors and Collaborators

Kowa Research Institute, Inc.

Investigators

Study Director:

Roger Morgan, M.D., FACS

Kowa Research Institute, Inc.

More Information

No publications provided

Responsible Party:	Kowa Research Institute, Inc. ( Roger Morgan, M.D., FACS / Chief Medical Officer )
Study ID Numbers:	K-134-2.01US
Study First Received:	October 30, 2008
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00783081 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kowa Research Institute, Inc.:

Intermittent Claudication
Peripheral Arterial Disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Cilostazol
Vasodilator Agents
Vascular Diseases
Anti-Asthmatic Agents
Fibrinolytic Agents
Arteriosclerosis
Cardiovascular Agents

Neuroprotective Agents
Signs and Symptoms
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Intermittent Claudication
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Arteriosclerosis
Neuroprotective Agents
Signs and Symptoms
Fibrin Modulating Agents
Therapeutic Uses
Cardiovascular Diseases
Arterial Occlusive Diseases
Cilostazol

Vascular Diseases
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Intermittent Claudication
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 07, 2009