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

Primary Purpose

Intermittent Claudication

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
K-134
Cilostazol 100 mg BID
Placebo
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring Intermittent Claudication, Peripheral Arterial Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

low dose K-134

mid dose K-134

high dose K-134

Comparator

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Improvement in peak walking time at 26 weeks

Secondary Outcome Measures

Improvement in claudication onset time at 26 weeks

Full Information

First Posted
October 30, 2008
Last Updated
March 21, 2012
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00783081
Brief Title
Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Intermittent Claudication, Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
387 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose K-134
Arm Type
Experimental
Arm Title
mid dose K-134
Arm Type
Experimental
Arm Title
high dose K-134
Arm Type
Experimental
Arm Title
Comparator
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
K-134
Intervention Description
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Intervention Type
Drug
Intervention Name(s)
Cilostazol 100 mg BID
Intervention Description
Cilostazol 100mg BID for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID for 26 weeks.
Primary Outcome Measure Information:
Title
Improvement in peak walking time at 26 weeks
Time Frame
26 Weeks
Secondary Outcome Measure Information:
Title
Improvement in claudication onset time at 26 weeks
Time Frame
26 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Morgan, M.D., FACS
Organizational Affiliation
Kowa Research Institute, Inc.
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Santa Rosa
State/Province
California
Country
United States
City
Vista
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Gulf Breeze
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Pensacola
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
St. Petersburg
State/Province
Florida
Country
United States
City
Aurora
State/Province
Illinois
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Hinsdale
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Auburn
State/Province
Maine
Country
United States
City
St Louis
State/Province
Missouri
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Danville
State/Province
Pennsylvania
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Amarillo
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
City
Gatchina
Country
Russian Federation
City
Irkutsk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Pskov
Country
Russian Federation
City
Saint-Petersburg
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
Smolensk
Country
Russian Federation
City
Sochi
Country
Russian Federation
City
Tomsk
Country
Russian Federation
City
Volgograd
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
21612611
Citation
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.
Results Reference
derived

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

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