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

Phase 2CompletedNCT00851500

Kowa Research Institute, Inc.210 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

210

Conditions

Atherosclerosis

Interventions

K-604DRUG

K-604 is given for 26 weeks

PlaceboOTHER

placebo tablets are given for 26 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * moderate carotid artery stenosis Exclusion Criteria: * history of arteritis * heavily calcified plaque * uncontrolled hypertension * poorly controlled diabetes * hypercholesterolemia

Locations (19)

Unnamed facility

Chandler, Arizona, United States

Unnamed facility

Litchfield Park, Arizona, United States

Unnamed facility

Phoenix, Arizona, United States

Outcomes

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

Data from ClinicalTrials.gov

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