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

Phase 2

Completed

• Conditions: Intermittent Claudication
• Interventions: Drug: K-134; Drug: Cilostazol 100 mg BID; Drug: Placebo

• Registration Number: NCT00783081
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Study Start: 2008-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose K-134	K-134	-
Comparator	Cilostazol 100 mg BID	-
Placebo	Placebo	-
low dose K-134	K-134	-
mid dose K-134	K-134	-

Primary Outcome Measures

Name	Time	Method
Improvement in peak walking time at 26 weeks	26 Weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in claudication onset time at 26 weeks	26 Weeks