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

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.
 
ClinicalTrials.gov Identifier: NCT00851500
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
Kowa Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: K-604 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: low dose K-604 Drug: K-604
K-604 is given for 26 weeks

Experimental: high dose K-604 Drug: K-604
K-604 is given for 26 weeks

Placebo Comparator: placebo Other: Placebo
placebo tablets are given for 26 weeks




Primary Outcome Measures :
  1. Change from baseline in plaque composition over 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline in plaque size over 6 months. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate carotid artery stenosis

Exclusion Criteria:

  • history of arteritis
  • heavily calcified plaque
  • uncontrolled hypertension
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00851500


Locations
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United States, Arizona
Chandler, Arizona, United States
Litchfield Park, Arizona, United States
Phoenix, Arizona, United States
United States, California
Los Angeles, California, United States
San Diego, California, United States
United States, Florida
Clearwater, Florida, United States
Jacksonville, Florida, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Buffalo, New York, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Texas
Carrollton, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Virginia Beach, Virginia, United States
United States, Washington
Olympia, Washington, United States
Renton, Washington, United States
Seattle, Washington, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.

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Responsible Party: Roger Morgan, MD Chief Medical Officer, Kowa Research Institute
ClinicalTrials.gov Identifier: NCT00851500     History of Changes
Other Study ID Numbers: K-604-2.01US
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: August 2011
Keywords provided by Kowa Research Institute, Inc.:
atherosclerosis
carotid artery disease
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
(2-(4-(2-benzimidazol-2ylthio)ethyl)piperazin-1yl)-N-(2,4-bis(methylthio)-6-methyl-3-pyridyl)acetamide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents