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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00783081
Other study ID # K-134-2.01US
Secondary ID
Status Completed
Phase Phase 2
First received October 30, 2008
Last updated March 21, 2012
Start date November 2008
Est. completion date July 2010

Study information

Verified date March 2012
Source Kowa Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 387
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Cilostazol 100 mg BID
Cilostazol 100mg BID for 26 weeks.
Placebo
Placebo BID for 26 weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kowa Research Institute, Inc.

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in peak walking time at 26 weeks 26 Weeks No
Secondary Improvement in claudication onset time at 26 weeks 26 Weeks No
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