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

NCT ID: NCT00851500

Last Updated: 2011-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low dose K-604

Group Type EXPERIMENTAL

K-604

Intervention Type DRUG

K-604 is given for 26 weeks

high dose K-604

Group Type EXPERIMENTAL

K-604

Intervention Type DRUG

K-604 is given for 26 weeks

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo tablets are given for 26 weeks

Interventions

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K-604

K-604 is given for 26 weeks

Intervention Type DRUG

Placebo

placebo tablets are given for 26 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* moderate carotid artery stenosis

Exclusion Criteria

* history of arteritis
* heavily calcified plaque
* uncontrolled hypertension
* poorly controlled diabetes
* hypercholesterolemia
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Kowa Research Institute

Locations

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Chandler, Arizona, United States

Site Status

Litchfield Park, Arizona, United States

Site Status

Phoenix, Arizona, United States

Site Status

Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

Clearwater, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

St Louis, Missouri, United States

Site Status

Buffalo, New York, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Carrollton, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Plano, Texas, United States

Site Status

Norfolk, Virginia, United States

Site Status

Virginia Beach, Virginia, United States

Site Status

Olympia, Washington, United States

Site Status

Renton, Washington, United States

Site Status

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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K-604-2.01US

Identifier Type: -

Identifier Source: org_study_id

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