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

May 17, 2006 updated by: Nissan Chemical Industries

A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NM-702 in Subjects With Intermittent Claudication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

390

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • 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
        • Investigator
    • Florida
      • Clearwater, Florida, United States, 33761
        • Investigator
      • Coral Gables, Florida, United States, 33134
        • Investigator
      • Jacksonville, Florida, United States, 32216
        • Investigator
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Investigator
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Investigator
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • Investigator
    • New York
      • New York, New York, United States, 10003
        • Investigator
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Investigator
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Investigator
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Investigator
    • Texas
      • San Antonio, Texas, United States, 43606
        • Investigator
    • Washington
      • Tacoma, Washington, United States, 98431
        • Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement in peak walking time at 24 weeks

Secondary Outcome Measures

Outcome Measure
Improvement in claudication onset time at 24 weeks
Health status survey questionnaire
Walking impairment questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nissan Chemical Industries

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

January 19, 2005

First Submitted That Met QC Criteria

January 19, 2005

First Posted (Estimate)

January 20, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2006

Last Update Submitted That Met QC Criteria

May 17, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-IC-0201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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