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

Verified by: Kowa Research Institute, Inc., March 2011
First Received: October 30, 2008 | Last Updated: March 22, 2011 | Phase: Phase 2 | Start Date: November 2008
Overall Status: Completed | Estimated Enrollment: 370
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The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication...

Brief Summary

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2010

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: low dose K-134
  • Experimental: mid dose K-134
  • Experimental: high dose K-134
  • Active Comparator: Comparator
  • Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Improvement in peak walking time at 26 weeks
    • Time Frame: 26 Weeks
      Safety Issue?: No

Secondary Measures

  • Improvement in claudication onset time at 26 weeks
    • Time Frame: 26 Weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Kowa Research Institute, Inc. Industry

Overall Clinical Trial Officials and Contacts

Roger Morgan, M.D., FACS Study Director Kowa Research Institute, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00783081

Study ID Number: K-134-2.01US

ClinicalTrials.gov Identifier: NCT00783081

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00783081