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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
History of Changes
  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:

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

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

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

ClinicalTrials.gov processed this record on May 16, 2013