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

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00851500
• Collaborator: (none)
• Enrollment: 210
• Locations: 19
• Arms: 3
• Duration (Months): 29.9
• Patients Per Site: 11.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Drug: K-604; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low dose K-604	Drug: K-604; K-604 is given for 26 weeks
Experimental: high dose K-604	Drug: K-604; K-604 is given for 26 weeks
Placebo Comparator: placebo	Other: Placebo; placebo tablets are given for 26 weeks

Outcome Measures

Primary Outcome Measures

1. Change from baseline in plaque composition over 6 months [6 months]

Secondary Outcome Measures

1. Change from baseline in plaque size over 6 months. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• moderate carotid artery stenosis

Exclusion Criteria:

• history of arteritis

• heavily calcified plaque

• uncontrolled hypertension

• poorly controlled diabetes

• hypercholesterolemia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chandler	Arizona	United States
2		Litchfield Park	Arizona	United States
3		Phoenix	Arizona	United States
4		Los Angeles	California	United States
5		San Diego	California	United States
6		Clearwater	Florida	United States
7		Jacksonville	Florida	United States
8		St. Louis	Missouri	United States
9		Buffalo	New York	United States
10		Oklahoma City	Oklahoma	United States
11		Carrollton	Texas	United States
12		Dallas	Texas	United States
13		Houston	Texas	United States
14		Plano	Texas	United States
15		Norfolk	Virginia	United States
16		Virginia Beach	Virginia	United States
17		Olympia	Washington	United States
18		Renton	Washington	United States
19		Seattle	Washington	United States

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00851500
• Other Study ID Numbers: K-604-2.01US
• First Posted: Feb 26, 2009
• Last Update Posted: Aug 17, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by , ,: atherosclerosis; carotid artery disease
• Additional relevant MeSH terms: Atherosclerosis

Study Results

No Results Posted as of Aug 17, 2011