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

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

Completed

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chandler, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

moderate carotid artery stenosis

Exclusion criteria

history of arteritis
heavily calcified plaque
uncontrolled hypertension
poorly controlled diabetes
hypercholesterolemia

Treatment and study plan

K-604

Drug

K-604 is given for 26 weeks

Placebo

Other

placebo tablets are given for 26 weeks

Primary outcomes

Change from baseline in plaque composition over 6 months

Time frame: 6 months

Secondary outcomes

Change from baseline in plaque size over 6 months.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Feb 26, 2009
Registry last updated: Aug 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed