Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication

Kowa

Status and phase: Completed; Phase 2

Conditions: Intermittent Claudication

Treatments: Drug: Placebo; Drug: Cilostazol 100 mg BID; Drug: K-134

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783081

K-134-2.01US

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.

Enrollment: 387 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable claudication symptoms

Exclusion criteria

• Lower extremity amputation
• Signs or symptoms of critical leg ischemia (CLI)
• Uncontrolled hypertension
• Tachycardia
• Poorly controlled diabetes
• Hypercholesterolemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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387 participants in 5 patient groups, including a placebo group

low dose K-134

Experimental group

Treatment:

Drug: K-134

mid dose K-134

Experimental group

Treatment:

Drug: K-134

high dose K-134

Experimental group

Treatment:

Drug: K-134

Comparator

Active Comparator group

Treatment:

Drug: Cilostazol 100 mg BID

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo