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Completed

NCT Number: NCT00783081

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

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

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Key information

Conditions

Intermittent Claudication Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gatchina, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K-134

Drug

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

Cilostazol 100 mg BID

Drug

Cilostazol 100mg BID for 26 weeks.

Placebo

Drug

Placebo BID for 26 weeks.

Primary outcomes

  1. Improvement in peak walking time at 26 weeks

    Time frame: 26 Weeks

Secondary outcomes

  1. Improvement in claudication onset time at 26 weeks

    Time frame: 26 Weeks

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 31, 2008
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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