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

Kowa

Status and phase: Completed; Phase 2

Conditions: Atherosclerosis

Treatments: Other: Placebo; Drug: K-604

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851500

K-604-2.01US

Details and patient eligibility

About

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

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate carotid artery stenosis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

low dose K-604

Experimental group

Treatment:

Drug: K-604

high dose K-604

Experimental group

Treatment:

Drug: K-604

placebo

Placebo Comparator group

Treatment:

Other: Placebo