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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00783081
First received: October 30, 2008
Last updated: March 21, 2012
Last verified: March 2012

October 30, 2008
March 21, 2012
November 2008
July 2010   (final data collection date for primary outcome measure)
Improvement in peak walking time at 26 weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Difference between the K-134 high dose group and placebo group in the change in PWT between baseline and Week 26, as measured by an ETT utilizing a modified Gardner protocol at trough drug concentration. [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00783081 on ClinicalTrials.gov Archive Site
Improvement in claudication onset time at 26 weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Differences between the K-134 high dose group and placebo group in the change in COT between baseline and Week 26. Baseline COT will be defined as the maximum COT from Visit 2 or Visit 3 (Baseline 1 or Baseline 2). [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Difference between the K-134 high dose group and placebo group in the change in PWT between baseline and Week 14. [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Changes over time between the K-134 high dose group and placebo group in ABI, quality of life (QOL) as measured by the SF-36v2® physical function subscale and the WIQ distance score, and exploratory biomarkers. [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
Not Provided

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Intermittent Claudication
  • 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.
  • Experimental: low dose K-134
    Intervention: Drug: K-134
  • Experimental: mid dose K-134
    Intervention: Drug: K-134
  • Experimental: high dose K-134
    Intervention: Drug: K-134
  • Active Comparator: Comparator
    Intervention: Drug: Cilostazol 100 mg BID
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Lewis RJ, Connor JT, Teerlink JR, Murphy JR, Cooper LT, Hiatt WR, Brass EP. Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication. Trials. 2011 May 25;12:134. doi: 10.1186/1745-6215-12-134.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
387
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation
 
NCT00783081
K-134-2.01US
Yes
Kowa Research Institute, Inc.
Kowa Research Institute, Inc.
Not Provided
Study Director: Roger Morgan, M.D., FACS Kowa Research Institute, Inc.
Kowa Research Institute, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP