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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00783081

Enrollment

387

Registered

2008-10-31

Start date

2008-11-30

Completion date

2010-07-31

Last updated

2012-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication

Keywords

Intermittent Claudication, Peripheral Arterial Disease

Brief summary

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

Interventions

DRUGK-134

K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.

DRUGCilostazol 100 mg BID

Cilostazol 100mg BID for 26 weeks.

DRUGPlacebo

Placebo BID for 26 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Improvement in peak walking time at 26 weeks	26 Weeks

Secondary

Measure	Time frame
Improvement in claudication onset time at 26 weeks	26 Weeks

Countries

Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026