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

Phase 2

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: K-604; Other: Placebo

• Registration Number: NCT00851500
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Primary Completion: 2011-06
• Status Verified: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-15
• Last Update Posted: 2011-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• moderate carotid artery stenosis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose K-604	K-604	-
placebo	Placebo	-
low dose K-604	K-604	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in plaque composition over 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in plaque size over 6 months.	6 months