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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 24, 2009

Last Updated Date

February 25, 2009

Start Date ^†

February 2009

Current Primary Outcome Measures ^†

Change from baseline in plaque composition over 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00851500 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change from baseline in plaque size over 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Atherosclerosis

Intervention ^†

Drug: K-604
Other: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

210

Completion Date

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

moderate carotid artery stenosis

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Roger Morgan, M.D., F.A.C.S

919-433-1600

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00851500

Responsible Party

Roger Morgan, MD Chief Medical Officer, Kowa Research Institute

Secondary IDs ^††

Study Sponsor ^†

Kowa Research Institute, Inc.

Collaborators ^††

Investigators ^†

Information Provided By

Kowa Research Institute, Inc.

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.