A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis

This study is currently recruiting participants.

Verified by Kowa Research Institute, Inc., July 2009

First Received: February 24, 2009 Last Updated: July 6, 2009 History of Changes

Sponsored by:	Kowa Research Institute, Inc.
Information provided by:	Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:	NCT00851500

Purpose

The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment of atherosclerosis.

Condition	Intervention	Phase
Atherosclerosis	Drug: K-604 Other: Placebo	Phase II

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

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

Primary Outcome Measures:

Change from baseline in plaque composition over 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in plaque size over 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	February 2009
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
low dose K-604: Experimental	Drug: K-604 K-604 is given for 26 weeks
high dose K-604: Experimental	Drug: K-604 K-604 is given for 26 weeks
placebo: Placebo Comparator	Other: Placebo placebo tablets are given for 26 weeks

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851500

Contacts

Contact: Roger Morgan, M.D., F.A.C.S

919-433-1600

Locations

United States, Arizona
	Recruiting
Chandler, Arizona, United States
	Recruiting
Litchfield Park, Arizona, United States
	Recruiting
Phoenix, Arizona, United States
United States, California
	Recruiting
San Diego, California, United States
United States, Florida
	Recruiting
Jacksonville, Florida, United States
	Recruiting
Clearwater, Florida, United States
United States, Missouri
	Recruiting
St. Louis, Missouri, United States
United States, Oklahoma
	Recruiting
Oklahoma City, Oklahoma, United States
United States, Texas
	Recruiting
Dallas, Texas, United States
	Recruiting
Houston, Texas, United States
	Recruiting
Plano, Texas, United States
	Recruiting
Carrollton, Texas, United States
United States, Virginia
	Recruiting
Norfolk, Virginia, United States
	Recruiting
Virginia Beach, Virginia, United States
United States, Washington
	Recruiting
Renton, Washington, United States
	Recruiting
Olympia, Washington, United States
	Recruiting
Seattle, Washington, United States

Sponsors and Collaborators

Kowa Research Institute, Inc.

More Information

No publications provided

Responsible Party:	Kowa Research Institute ( Roger Morgan, MD Chief Medical Officer )
Study ID Numbers:	K-604-2.01US
Study First Received:	February 24, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00851500 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kowa Research Institute, Inc.:

atherosclerosis
carotid artery disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Carotid Artery Diseases

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis

ClinicalTrials.gov processed this record on September 10, 2009