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

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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

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

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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