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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00783081
First received: October 30, 2008
Last updated: March 21, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in claudication onset time at 26 weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783081

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Beverly Hills, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Santa Rosa, California, United States
Vista, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Florida
Clearwater, Florida, United States
Gulf Breeze, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Pensacola, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
United States, Illinois
Aurora, Illinois, United States
Chicago, Illinois, United States
Hinsdale, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Maine
Auburn, Maine, United States
United States, Missouri
St Louis, Missouri, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Danville, Pennsylvania, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Amarillo, Texas, United States
Houston, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Russian Federation
Gatchina, Russian Federation
Irkutsk, Russian Federation
Moscow, Russian Federation
Novosibirsk, Russian Federation
Pskov, Russian Federation
Saint-Petersburg, Russian Federation
Saratov, Russian Federation
Smolensk, Russian Federation
Sochi, Russian Federation
Tomsk, Russian Federation
Volgograd, Russian Federation
Yaroslavl, Russian Federation
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
Study Director: Roger Morgan, M.D., FACS Kowa Research Institute, Inc.
  More Information

No publications provided by Kowa Research Institute, Inc.

Additional 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
Study First Received: October 30, 2008
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 27, 2014