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Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication

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.
 
ClinicalTrials.gov Identifier: NCT00102050
Recruitment Status : Completed
First Posted : January 20, 2005
Last Update Posted : May 19, 2006
Sponsor:
Information provided by:
Nissan Chemical Industries

Study Description
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Brief Summary:
NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 taken twice a day (BID) for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.

Condition or disease Intervention/treatment Phase
Intermittent Claudication Peripheral Vascular Disease Drug: NM-702 (phosphodiesterase inhibitor) Phase 2

Detailed Description:
NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 BID for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NM-702 in Subjects With Intermittent Claudication
Study Start Date : April 2003
Study Completion Date : April 2006
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Improvement in peak walking time at 24 weeks

Secondary Outcome Measures :
  1. Improvement in claudication onset time at 24 weeks
  2. Health status survey questionnaire
  3. Walking impairment questionnaire

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
  • Median treadmill peak walking time between 90 and 600 seconds

Exclusion Criteria:

  • Symptoms of limb threatening ischemia (ischemic rest pain, ischemic ulceration and/or gangrene)
  • Clinically significant pulmonary, neurological or skeletal dysfunction (e.g., lumbar canal stenosis, emphysema, uncontrolled angina, multiple sclerosis, or gait altering amputation) that would directly interfere or limit exercise testing
  • Subjects who have had, or will require, a peripheral revascularization procedure within 12 weeks prior to or following treatment initiation.
  • A resting blood pressure greater than 150/100 and other clinically significant results.
Contacts and Locations
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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): NCT00102050


Locations
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United States, California
Investigator
Long Beach, California, United States, 90822
Investigator
Riverside, California, United States, 92501
Investigator
San Diego, California, United States, 92121
Investigator
San Francisco, California, United States, 94121
Investigator
Torrance, California, United States, 90502
United States, Florida
Investigator
Clearwater, Florida, United States, 33761
Investigator
Coral Gables, Florida, United States, 33134
Investigator
Jacksonville, Florida, United States, 32216
United States, Illinois
Investigator
Springfield, Illinois, United States, 62702
United States, Kansas
Investigator
Shawnee Mission, Kansas, United States, 66204
United States, Louisiana
Investigator
New Orleans, Louisiana, United States, 70124
United States, New York
Investigator
New York, New York, United States, 10003
United States, North Carolina
Investigator
Durham, North Carolina, United States, 27705
United States, Ohio
Investigator
Toledo, Ohio, United States, 43606
United States, Rhode Island
Investigator
Warwick, Rhode Island, United States, 02886
United States, Texas
Investigator
San Antonio, Texas, United States, 43606
United States, Washington
Investigator
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Nissan Chemical Industries
More Information
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ClinicalTrials.gov Identifier: NCT00102050    
Other Study ID Numbers: NCI-IC-0201
First Posted: January 20, 2005    Key Record Dates
Last Update Posted: May 19, 2006
Last Verified: May 2006
Keywords provided by Nissan Chemical Industries:
NM-702 tablets
intermittent claudication
peripheral
 arterial
vascular
peripheral arterial disease
Additional relevant MeSH terms:
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Vascular Diseases
Intermittent Claudication
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Atherosclerosis
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action