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

Last updated: May 17, 2006
Sponsor: Nissan Chemical Industries
Overall Status: Completed

Phase

2

Condition

Vascular Diseases

Circulation Disorders

Peripheral Arterial Occlusive Disease

Treatment

N/A

Clinical Study ID

NCT00102050
NCI-IC-0201
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Stable, symptomatic, intermittent claudication due to occlusive atheroscleroticdisease of the lower extremities

  • Median treadmill peak walking time between 90 and 600 seconds

Exclusion

Exclusion Criteria:

  • Symptoms of limb threatening ischemia (ischemic rest pain, ischemic ulceration and/organgrene)

  • Clinically significant pulmonary, neurological or skeletal dysfunction (e.g., lumbarcanal stenosis, emphysema, uncontrolled angina, multiple sclerosis, or gait alteringamputation) that would directly interfere or limit exercise testing

  • Subjects who have had, or will require, a peripheral revascularization procedurewithin 12 weeks prior to or following treatment initiation.

  • A resting blood pressure greater than 150/100 and other clinically significantresults.

Study Design

Total Participants: 390
Study Start date:
April 01, 2003
Estimated Completion Date:
April 30, 2006

Study 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.

Connect with a study center

  • Investigator

    Long Beach, California 90822
    United States

    Site Not Available

  • Investigator

    Riverside, California 92501
    United States

    Site Not Available

  • Investigator

    San Diego, California 92121
    United States

    Site Not Available

  • Investigator

    San Francisco, California 94121
    United States

    Site Not Available

  • Investigator

    Torrance, California 90502
    United States

    Site Not Available

  • Investigator

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Investigator

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Investigator

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Investigator

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Investigator

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

  • Investigator

    New Orleans, Louisiana 70124
    United States

    Site Not Available

  • Investigator

    New York, New York 10003
    United States

    Site Not Available

  • Investigator

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Investigator

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Investigator

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Investigator

    San Antonio, Texas 43606
    United States

    Site Not Available

  • Investigator

    Tacoma, Washington 98431
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.