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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00783081
First Posted: October 31, 2008
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
  Purpose
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.

Condition Intervention Phase
Intermittent Claudication Drug: K-134 Drug: Cilostazol 100 mg BID Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:
  • Improvement in peak walking time at 26 weeks [ Time Frame: 26 Weeks ]

Secondary Outcome Measures:
  • Improvement in claudication onset time at 26 weeks [ Time Frame: 26 Weeks ]

Enrollment: 387
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low dose K-134 Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Experimental: mid dose K-134 Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Experimental: high dose K-134 Drug: K-134
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Active Comparator: Comparator Drug: Cilostazol 100 mg BID
Cilostazol 100mg BID for 26 weeks.
Placebo Comparator: Placebo Drug: Placebo
Placebo BID for 26 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783081


  Show 42 Study Locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
Study Director: Roger Morgan, M.D., FACS Kowa Research Institute, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00783081     History of Changes
Other Study ID Numbers: K-134-2.01US
First Submitted: October 30, 2008
First Posted: October 31, 2008
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by Kowa Research Institute, Inc.:
Intermittent Claudication
Peripheral Arterial Disease

Additional relevant MeSH terms:
Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors