Clinical Trial: Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.
Detailed Summary:
Sponsor: Kowa Research Institute, Inc.
Current Primary Outcome: Improvement in peak walking time at 26 weeks [ Time Frame: 26 Weeks ]
Original Primary Outcome: 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 ]
Current Secondary Outcome: Improvement in claudication onset time at 26 weeks [ Time Frame: 26 Weeks ]
Original Secondary Outcome:
- 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 ]
- 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 ]
- 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 ]
Information By: Kowa Research Institute, Inc.
Dates:
Date Received: October 30, 2008
Date Started: November 2008
Date Completion:
Last Updated: March 21, 2012
Last Verified: March 2012
