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

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ClinicalTrials.gov Identifier: NCT00783081
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 22, 2012
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol
U.S. FDA Resources

Arm Intervention/treatment
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.



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

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


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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

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.

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 Posted: October 31, 2008    Key Record Dates
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