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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851500

Enrollment

210

Registered

2009-02-26

Start date

2009-02-28

Completion date

2011-08-31

Last updated

2011-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

atherosclerosis, carotid artery disease

Brief summary

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

Interventions

DRUGK-604

K-604 is given for 26 weeks

OTHERPlacebo

placebo tablets are given for 26 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* moderate carotid artery stenosis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in plaque composition over 6 months	6 months

Secondary

Measure	Time frame
Change from baseline in plaque size over 6 months.	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026