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

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
K-604
Placebo
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring atherosclerosis, carotid artery disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate carotid artery stenosis

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

low dose K-604

high dose K-604

placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in plaque composition over 6 months

Secondary Outcome Measures

Change from baseline in plaque size over 6 months.

Full Information

First Posted
February 24, 2009
Last Updated
August 15, 2011
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00851500
Brief Title
A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
atherosclerosis, carotid artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low dose K-604
Arm Type
Experimental
Arm Title
high dose K-604
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
K-604
Intervention Description
K-604 is given for 26 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo tablets are given for 26 weeks
Primary Outcome Measure Information:
Title
Change from baseline in plaque composition over 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in plaque size over 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate carotid artery stenosis Exclusion Criteria: history of arteritis heavily calcified plaque uncontrolled hypertension poorly controlled diabetes hypercholesterolemia
Facility Information:
City
Chandler
State/Province
Arizona
Country
United States
City
Litchfield Park
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Carrollton
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Virginia Beach
State/Province
Virginia
Country
United States
City
Olympia
State/Province
Washington
Country
United States
City
Renton
State/Province
Washington
Country
United States
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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