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

Intermittent Claudication Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783081
• Other study ID #: K-134-2.01US
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2008
• Last updated: March 21, 2012
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2012
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Drug:
• K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
• Cilostazol 100 mg BID
Cilostazol 100mg BID for 26 weeks.
• Placebo
Placebo BID for 26 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in peak walking time at 26 weeks		26 Weeks	No
Secondary	Improvement in claudication onset time at 26 weeks		26 Weeks	No