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

NCT00783081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2012-03-22

No results posted yet for this study

Summary

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

Conditions

  • Intermittent Claudication

Interventions

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.

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger Morgan, M.D., FACS · Kowa Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00783081 on ClinicalTrials.gov