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

This study has been completed.

First Received on October 30, 2008. Last Updated on March 21, 2012 History of Changes

Sponsor:	Kowa Research Institute, Inc.
Information provided by (Responsible Party):	Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:	NCT00783081

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):

Lewis RJ, Connor JT, Teerlink JR, Murphy JR, Cooper LT, Hiatt WR, Brass EP. Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication. Trials. 2011 May 25;12:134.

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 24, 2012