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

March 21, 2012 updated by: Kowa Research Institute, Inc.
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

387

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Gatchina, Russian Federation
      • Irkutsk, Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • Pskov, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Saratov, Russian Federation
      • Smolensk, Russian Federation
      • Sochi, Russian Federation
      • Tomsk, Russian Federation
      • Volgograd, Russian Federation
      • Yaroslavl, Russian Federation
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Beverly Hills, California, United States
      • Los Angeles, California, United States
      • Sacramento, California, United States
      • Santa Rosa, California, United States
      • Vista, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Florida
      • Clearwater, Florida, United States
      • Gulf Breeze, Florida, United States
      • Hialeah, Florida, United States
      • Jacksonville, Florida, United States
      • Pensacola, Florida, United States
      • Sarasota, Florida, United States
      • St. Petersburg, Florida, United States
    • Illinois
      • Aurora, Illinois, United States
      • Chicago, Illinois, United States
      • Hinsdale, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maine
      • Auburn, Maine, United States
    • Missouri
      • St Louis, Missouri, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Danville, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Texas
      • Amarillo, Texas, United States
      • Houston, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo BID for 26 weeks.
Active Comparator: Comparator
Drug: Cilostazol 100 mg BID
Cilostazol 100mg BID for 26 weeks.
Experimental: low dose K-134
Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Experimental: mid dose K-134
Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Experimental: high dose K-134
Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in peak walking time at 26 weeks
Time Frame: 26 Weeks
26 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in claudication onset time at 26 weeks
Time Frame: 26 Weeks
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-134-2.01US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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